medical_device

medical_device

medical_device

1412161, 1410201, 1410271, 1412121, and 1412081

General and Plastic Surgery Devices

2

No

Worldwide - US distribution in the states of FL, OH, and the country of Spain.

Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S || Peoduct Usage: || For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.

Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006

General and Plastic Surgery Devices

2

No

Distributed in the states of CA, and TX and in the country of Mexico.

Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.

Lot Numbers: 1) 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136; 2) 569462, 577800, 577971 & 579652; 3) 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales

Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 || The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.

Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. || Intended to be used for the dispersion and return to the electrosurgical generator.

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 || The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

Beginning Lot Code 110609X to Ending Lot Code 20160308X

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

CORE¿ Trumpet Handpiece only, Catalog Number CD8450 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

All lots codes manufactured from 09/01/2011 through 11/17/2015: 267221, 301001, 309889, 318652, 319649, 325019, 354759, 334627, 336041, 341704, 343927, 349952, 384294, 354768, 365239, 369773, 374480, 378521, 406137, 385695, 388538, 392382, 394178, 396542, 436808, 413702, 456341, 423877, 427704, 433503, 478513, 451923, 488101, 464062, 468012, 471297, 511327, 482366, 522335, 494840, 499981, 505321, 544240, 515060, 551152, 527734, 531802, 536700, 581072, 550988, 590037, 557461, 570449, 574167, 611804, 588892, 621304, 597982, 598682, 605515, 643396, 619686, 656909, 629202, 634911, 643395, 676005, 654991, 692617, 667118, 671471, 674410, 683144, 695062, 695063, 297982.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US Nationwide in the states of: CA, HI, IL, IN, KS, LA, MA, NC, NM, NY, OH, OK, PA, TN, TX, UT, WA and WI; plus Foreign distribution to Australia, Canada, France, Germany, Italy, Spain, Czech Republic, Lithuania, Netherlands, Poland, Korea,Morocco, Malaysia, Mexico, Taiwan, and South Africa.

CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only || Product Usage: || The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

Serial Numbers: 1540139, 15280024, 15420101, 15470153, 15510179, 16010007, 1540144, 15280026, 15420102, 15470161, 15510182, 16010008, 15250002, 15290032, 15430106, 15490169, 15510186, 16010009, 15250004, 15290033, 15430107, 15490170, 15510189, 16010010,  15250005, 15300038, 15430110, 15490172, 15510190, 16430108, 15250006, 15350041, 15430111, 15500173, 15510192, 16430109, 15250007, 15350043, 15430113, 15500174, 16010001, 16430112, 15250008, 15350044, 15430114, 15500175, 16010002, 15260010, 15360054, 15430115, 15500176, 16010003, 15260012, 15360057, 15460140, 15500177, 16010004, 15260013, 15360059, 15460142, 15510178, 16010005, 15280023, 15360060, 15460146, 15510179, 16010006.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502

Serial Numbers: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 1618330 16020103 16070493 16110884 16171280 16231667 16382088 16412486 16442885 16493285 13181360 16020104 16070494 16110885 16171281 16231668 16382089 16412487 16442886 16493286 15010013 16020105 16070495 16120886 16171282 16231669 16382090 16412488 16442887 16493287 15070434 16020106 16070496 16120887 16171283 16231670 16382091 16412489 16442888 16493288 15221592 16020107 16070497 16120888 16171284 16231671 16382092 16412490 16442889 16493289 15221593 16020108 16070498 16120889 16171285 16231672 16382093 16412491 16442890 16493290 15221594 16020109 16070499 16120890 16171286 16231673 16382094 16412492 16442891 16493291 15221595 16020110 16070500 16120891 16171287 16231674 16382095 16412493 16442892 16493292 15221596 16020111 16080501 16120892 16171288 16231675 16382096 16412494 16442893 16493293 15221597 16020112 16080502 16120893 16171289 16231676 16382097 16412495 16442894 16493294 15221598 16020113 16080503 16120894 16171290 16231677 16382098 16412496 16442895 16493295 15221599 16020114 16080504 16120895 16171291 16231678 16382099 16412497 16442896 16493296 15221600 16020115 16080505 16120896 16171292 16231679 16382100 16412498 16442897 16493297 15240221 16020116 16080506 16120897 16171293 16231680 16382101 16412499 16442898 16493298 15250297 16020117 16080507 16120898 16171294 16231681 16382102 16412500 16442899 16493299 15300642 16020118 16080508 16120899 16171295 16231682 16382103 16412501 16442900 16493301 15300651 16020119 16080509 16120900 16171296 16231683 16382104 16412502 16442901 16493302 15320844 16020120 16080510 16120901 16171297 16231684 16382105 16412503 16442902 16493303 15320846 16020121 16080511 16120902 16171298 16231685 16382106 16412504 16442903 16493304 15320849 16020122 16080512 16120903 16171299 16231686 16382107 16412505 16442904 16493305 15330856 16020123 16080513 16120904 16171300 16231687 16382108 16412506 16442905 16493306 15330860 16020124 16080514 16120905 16171301 16231688 16382109 16412507 16442906 16493307 15330866 16020125 16080515 16120906 16171302 16231689 16382110 16412508 16442907 16493308 15330905 16020126 16080516 16120907 16171303 16231690 16382111 16412509 16442908 16493309 15330909 16020127 16080517 16120908 16171304 16231691 16382112 16412510 16442909 16493310 15340913 16020128 16080518 16120909 16171305 16231692 16382113 16412511 16442910 16493311 15340915 16020129 16080519 16120910 16171306 16231693 16382114 16412512 16442911 16493312 15340918 16020130 16080520 16120911 16171307 16231694 16382115 16412513 16442912 16493313 15340920 16020131 16080521 16120912 16171308 16231695 16382116 16412514 16442913 16493314 15340924 16020132 16080522 16120913 16171309  16231696 16382117 16412515 16442914 16493315 15340990 16020133 16080523 16120914 16171310 16231697 16382118 16412516 16442915 16493316 15340999 16020134 16080524 16120915 16171311 16231698 16382119 16412517 16442916 16493317 15351005 16020135 16080525 16120916 16171312  16231699 16382120 16412518 16442917 16493318 15351009 16020136 16080526 16120917 16171313 16231700 16382121 16412519 16442918 16493319 15351012 16020137 16080527 16120918 16171314 16231701 16382122 16412520 16442919 16493320 15351014 16020138 16080528 16120919 16171315 16231702 16382123 16412521 16442920 16493321 15351015 16020139 16080529 16120920 16181316 16231703 16382124 16412522 16452921 16493322 15351017 16020140 16080530 16120921 16181317 16231704 16382125 16412523 16452922 16493323 15351019 16030092 16080531 16120922 16181318 16231705 16382126 16412524 16452923 16493324 15351026 16040141 16080532 16120923 16181319 16231706 16382127 16412525 16452924 16493325 15351028 16040142 16080533 16120924 16181321 16231707 16382128 16412526 16452925 16493326 15351030 16040143 16080534 16120925 16181322 16231708 16382129 16412527 16452926 16493327 15401355 16040144 16080535 16120926 16181323 16231709 16382130 16412528 16452927 16493328 15401356 16040145 16080536 16120927 16181323 16231710 16382131 16412529 16452928 16493329 15401357 16040146 16080537 16120928 16181324 16241711 16382132 16412530 16452929 16493330 15401358 16040147 16080538 16120929 16181325 16241712 16382133 16412531 16452930 16503331 15401359 16040148 16080539 16120930 16181326 16241713 16382134 16412532 16452931 16503332 15401360 16040149 16080540 16120931 16181327 16241714 16382135 16412533 16452932 16503333 15401361 16040150 16080541 16120932 16181328 16241715 16382136 16412534 16452933 16503334 15401362 16040151 16080542 16120933 16181329 16241716 16382137 16412535 16452934 16503335 15401363 16040152 16080543 16120934 16181330 16241717 16382138 16412536 16452935 16503336 15401364 16040153 16080544 16120935 16181331 16241718 16382139 16412537 16452936 16503337 15401365 16040154 16080545 16120936 16181332 16241719 16382140 16412538 16452937 16503338 15401366 16040155 16080546 16120937 16181333 16241720 16382141 16412539 16452938 16503339 15401367 16040156 16080547 16120938 16181334 16241721 16382142 16412540 16452939 16503340 15401368 16040157 16080548 16120939 16181334 16241722 16382143 16412541 16452940 16503341 15401369 16040158 16080549 16120940 16181335 16241723 16382144 16412542 16452941 16503343 15401370 16040159 16080550 16120941 16181336 16241724 16382145 16412543 16452942 16503344 15401371 16040160 16080551 16120942 16181337 16241725 16382146 16412544 16452943 16503345 15401372 16040161 16080552 16120943 16181338 16241726 16382147 16412545 16452944 16503346 15401373 16040162 16080553 16120944 16181339 16241727 16382148 16412546 16452945 16503347 15401374 16040163 16080554 16120945 16181340 16241728 16382149 16412547 16452946 16503348 15401375 16040164 16080555 16120946 16181341  16241729 16382150 16412548 16452948 16503349 15401376 16040165 16080556 16120947 16181342 16241730 16382151 16412549 16452949 16503350 15401377 16040166 16080557 16120948 16181343 16241731 16382152 16412550 16452950 16503352 15401378 16040167 16080558 16120949 16181344  16241732 16382153 16412551 16452951 16503353 15401379 16040168 16080559 16120950 16181345 16241733 16382154 16412552 16452952 16503354 15401380 16040169 16080560 16120951 16181346 16241734 16382155 16412553 16452953 16503355 15401381 16040170 16080561 16120952 16181348 16241735 16382156 16412554 16452954 16503356 15401382 16040171 16080562 16120953 16181349 16241736 16382157 16412555 16452955 16503357 15401383 16040172 16080563 16120954 16181350 16241737 16382158 16412556 16452956 16503358 15401384 16040173 16080564 16120955 16181351 16241738 16382159 16412557 16452957 16503359 15401385 16040174 16080565 16120956 16181352 16241739 16382160 16412558 16452958 16503360 15401386 16040175 16080566 16120957 16181353 16241740 16382161 16412559 16452959 16503361 15401387 16040176 16080567 16120958 16181354 16241741 16382162 16412560 16452960 16503362 15401388 16040177 16080568 16120959 16181355 16241742 16382163 16412561 16452961 16503363 15401389 16040178 16080569 16120960 16181356 16241743 16382164 16412562 16452962 16503364 15401390 16040179 16080570 16120961 16181357 16241744 16382165 16412563 16452963 16503365 15401391 16040180 16080571 16120962 16181358 16241745 16382166 16412564 16452964 16503366 15401392 16040181 16080572 16120963 16181359 16241746 16382167 16412565 16452965 16503367 15401393 16040182 16080573 16120964 16181360 16241747 16382168 16412566 16452966 16503368 15401394 16040183 16080574 16120965 16181361 16241748 16382169 16412567 16452967 16503369 15401395 16040184 16080575 16120966 16181362 16241749 16382170 16412568 16452968 16503370 15401396 16040185 16080576 16120967 16181363  16241750 16382171 16412569 16452969 16503371 15401397 16040186 16080577 16120968 16181364 16251771 16382172 16412570 16452970 16503372 15401398 16040187 16080578 16120969 16181364 16251772 16382173 16412571 16452971, 16503373 15401399 16040188 16080579 16120970 16181365 16251773 16382174 16412572 16452972 16503374 15401400 16040189 16080580 16120971 16181366 16251774 16382175 16412573 16452973 16503375 15401401 16040190 16080581 16120972 16181367 16251775 16382176 16412574 16452974 16503376 15401402 16040191 16080582 16120973 16181368 16251776 16382177 16412575 16452975 16503377 15401403 16040192 16080583 16120974 16181369 16251777 16382178 16412576 16452976 16503378 15401404 16040193 16080584 16120975 16181370 16251778 16382179 16412577 16452977 16503379 15411405 16040194 16080585 16120976 16181371 16251779 16382180 16412578 16452978 16503380 15411406 16040195 16080586 16120977 16181372 16251780 16382181 16412579 16452979 16503381 15411407 16040196 16080587 16120978 16181373 16351781 16382182 16412580 16452980 16503382 15411408 16040197 16080588 16120979 16181374 16351782 16382183 16412581 16452981 16503383 15411409 16040198 16080589 16120980 16181375 16351783 16382184 16412582 16452982 16503384 15411410 16040199 16080590 16120981 16181376 16351784 16382185 16412583 16452983 16503385 15411411 16040200 16080591 16120982 16181377 16351785 16382186 16412584 16452984 16503386 15411412 16040201 16080592 16120983 16181378 16351786 16382187 16412585 16452985 16503387 15411413 16040202 16080593 16120984 16181379 16351787 16382188 16412586 16452986 16503388 15411414 16040203 16080594 16120985 16181380 16351788 16382189 16412587 16452987 16503389 15411415  16040204 16080594 16120986 16181381 16351789 16382190 16412588 16452988 16503390 15411416 16040205 16080595 16120987 16181382 16351790 16382191 16412589 16452989 16503391 15411417 16040206 16080596 16120988 16181383 16351791 16382192 16412590 16452990 16503392 15411418  16040207 16080597 16120989 16181384 16351792 16382193 16412591 16452991 16503393 15411419 16040208 16080598 16120990 16181385 16351793 16382194 16412592 16452992 16503394 15411420 16040209 16080599 16120991 16181386 16351794 16382195 16412593 16452993 16503395 15492050 16040210 16080600 16120992 16181387 16351795 16392196 16412594 16452994 16503396 15492051 16040211 16080601 16120993 16181388 16351796 16392197 16412595 16452995 16503397 15492052 16040212 16080602 16120994 16181389 16351797 16392198 16422360 16452996 16503398 15492053 16040213 16080603 16120995 16181390 16351798 16392199 16422596 16452997 16503399 15492054 16040214 16080604 16120996 16181391 16351799 16392200 16422597 16452998 16503400 15492055 16040215 16080605 16120997 16181392 16351800 16392201 16422598 16452999 16503402 15492056 16041064 16080606 16120998 16181393 16351801 16392202 16422599 16453000 16503403 15492057 16050069 16080607 16120999 16181394 16351802 16392203 16422600 16462947 16503404 15492058 16050216 16080608 16121000 16181395 16351803 16392204 16422601 16463001 16503405 15492059 16050217 16080609 16121001 16181396 16351804 16392205 16422602 16463002 16503406 15492060 16050218 16080610 16121002 16181397 16351805 16392206 16422603 16463003 16503407 15492061 16050219 16080611 16121003 16181398 16351806 16392207 16422604 16463004 16503408 15492062  16050220 16080611 16121004 16181399 16351807 16392208  16422605 16463005 16503409 15492063 16050221 16080612 16121005 16181400 16351808 16392209 16422606 16463006 16503410 15492064 16050222 16080613 16131006 16181401 16351809 16392210 16422607 16463007 16503411 15492065 16050223 16080614 16131007 16181402 16351810 16392211 16422608 16463008 16503412 15492066 16050224 16080615 16131008 16181403 16351811 16392212 16422609 16463009 16503413 15492067 16050225 16090616 16131009 16181404 16351812 16392213 16422610 16463010 16503413 15492068  16050226 16090617 16131010 16181405 16351813 16392214 16422611 16463011 16503414 15492069 16050227 16090618 16131011 16181406 16351814 16392215 16422612 16463012 16503415 15492070 16050228 16090619 16131012 16181407 16351815 16392216 16422613 16463013 16503416 15492071 16050229 16090620 16131013 16181408 16351816 16392217 16422614 16463014 16503418 15492072 16050230 16090621 16131014 16181409 16351817 16392218 16422615 16463015 16503419 15492073 16050231 16090622 16131015 16181410 16351818 16392219 16422616 16463016 16503420 15492074 16050232 16090623 16131016 16191350 16351819 16392220 16422617 16463017 16513421 15492075 16050233 16090624 16131017 16191351 16351820 16392221 16422618 16463018 16513422 15492076 16050234 16090625 16131018 16191352 16351821 16392222 16422619 16463019 16513423 15492077  16050235 16090626 16131019 16191353 16351822 16392223 16422620 16463020 16513424 15492078 16050236 16090627 16131020 16191354 16351823 16392224 16422621 16463021 16513425 15492079 16050237 16090628 16131021 16191355 16351824 16392225 16422622 16463022 16513426 15492080 16050238 16090629 16131022 16191411 16351825 16392226 16422623 16463023 16513427 15492081 16050239 16090630 16131023 16191412 16351826 16392227 16422624 16463024 16513428 15492082 16050240 16090631 16131024 16191413 16351827 16392228 16422625 16463025 16513429 15492083  16050241 16090632 16131025 16191414 16351828 16392229 16422627 16463026 16513430 15492084 16050242 16090633 16131026 16191415 16351829 16392230 16422628 16463027 16513431 15492085 16050243 16090634 16131027 16191416 16351830 16392231 16422629 16463028 16513432 15492086  16050244 16090635 16131028 16191417 16351831 16392232 16422631 16463029 16513433 15492087 16050245 16090636 16131029 16191418 16351832 16392233 16422632 16463030 16513434 15492088 16050246 16090637 16131030 16191419 16351833 16392234 16422633 16463031 16513435 15492089  16050247 16090638 16131031 16191420 16351834 16392235 16422634 16463032 16513436 15492090 16050248 16090639 16131032 16191421 16351835 16392236 16422635 16463033 16513437 15492091 16050249 16090639 16131033 16191422 16351836 16392237 16422636 16463034 16513438 15492092 16050250 16090640 16131034 16191423 16351837 16392238 16422637 16463035 16513439 15492093 16050251 16090641 16131035 16191424 16351838 16392239 16422638 16463036 16513440 15492094 16050252 16090641 16131036 16191425 16351839 16392240 16422639 16463037 16513441 15492095  16050253 16090642 16131037 16191426 16351840 16392241 16422640 16463038 16513442 15492096 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16372038 16402436 16442834 16483234 16010053 16070450 16110836 16161234 16221619 16372039 16402437 16442835 16483235 16010054 16070450 16110837 16161235 16221620 16372040 16402438 16442836 16483236 16010055 16070451 16110838 16161236 16221621 16372041 16402439 16442837 16483237 16010056 16070451 16110839 16161237 16221622 16372042 16402440 16442838 16483238 16010057 16070452 16110840 16161237 16221623 16372043 16402441 16442839 16483239 16010058 16070452 16110841 16161238 16221624 16372044 16402442 16442840 16483240 16010059 16070453 16110842 16161238 16221625 16372045 16402443 16442841 16483241 16010060 16070453 16110843 16161239 16221626 16372046 16402444 16442842 16483242 16010061 16070454 16110844 16161240 16221627 16372047 16402445 16442843 16483243 16010062 16070454 16110845 16161290 16221628 16372048 16402446 16442844 16483244 16010063 16070455 16110846 16171241 16221629 16372049 16402447 16442845 16483245 16010064 16070455 16110847 16171242 16221630 16372050 16402448 16442846 16483246 16010065 16070456 16110848 16171243 16221631 16372051 16402449 16442847 16483247 16010066 16070457 16110849 16171244 16221632 16372052 16402450 16442848 16483248 16010067 16070458 16110850 16171245 16221633 16372053 16402451 16442849 16483249 16010068 16070459 16110851 16171246 16221634 16372054 16402452 16442850 16493251 16010069 16070460 16110852 16171247 16221635 16372055 16402453 16442851 16493252 16010070 16070461 16110853 16171248 16221636 16372056 16402454 16442853 16493253 16020071 16070462 16110854 16171249 16221637 16372057 16402455 16442854 16493254 16020072 16070463 16110855 16171250 16221638 16372058 16402456 16442855 16493255 16020073 16070464 16110856 16171251 16221639 16372059 16402457 16442856 16493256 16020074 16070465 16110856 16171252 16221640 16372060 16402458 16442857 16493257 16020075 16070466 16110857 16171253 16221641 16372061 16402459 16442858 16493258 16020076 16070467 16110858 16171254 16221642 16372062 16402460 16442859 16493259 16020077 16070468 16110859 16171255 16221643 16372063 16402461 16442860 16493260 16020078 16070469 16110860 16171256 16221644 16372064 16402462 16442861 16493261 16020079 16070470 16110861 16171257 16221645 16372065 16402463 16442862 16493262 16020080 16070471 16110862 16171258 16221646 16372066 16402464 16442863 16493263 16020081 16070472 16110863 16171259 16221647 16372067 16402465 16442864 16493264 16020082 16070473 16110864 16171260 16221648 16372068 16402466 16442865 16493265 16020083 16070474 16110865 16171261 16221649 16372069 16402467 16442866 16493266 16020084 16070475 16110866 16171262 16221650 16372070 16402468 16442867 16493267 16020085 16070476 16110867 16171263 16231622 16372071 16402469 16442868 16493268 16020086 16070477 16110868 16171264 16231651 16372072 16402470 16442869 16493269 16020087 16070478 16110869 16171265 16231652 16372073 16402471 16442870 16493270 16020088 16070479 16110870 16171266 16231653 16372074 16402472 16442871 16493271 16020089 16070480 16110871 16171267 16231654 16372075 16402473 16442872 16493272 16020090 16070481 16110872 16171268 16231655 16382076 16402474 16442873 16493273 16020091 16070482 16110873 16171269 16231656 16382077 16402475 16442874 16493274 16020093 16070483 16110874 16171270 16231657 16382078 16402476 16442875 16493275 16020094 16070484 16110875 16171271 16231658 16382079 16402477 16442876 16493276 16020095 16070485 16110876 16171272 16231659 16382080 16402478 16442877 16493277 16020096 16070486 16110877 16171273 16231660 16382081 16402479 16442878 16493278 16020097 16070487 16110878 16171274 16231661 16382082 16402480 16442879 16493279 16020098 16070488 16110879 16171275 16231662 16382083 16402481 16442880 16493280 16020099 16070489 16110880 16171276 16231663 16382084 16402482 16442881 16493281 16020100 16070490 16110881 16171277 16231664 16382085 16402483 16442882 16493282 16020101 16070491 16110882 16171278 16231665 16382086 16402484 16442883 16493283

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 || The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.

Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187,  16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190,  16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193,  16500266, 15400256, 15480435, 15500488, 16040049, 16180096,  16260140, 16410194, 16500267, 15400257, 15480436, 15500489, 16040050, 16180097, 16260141, 16410195, 16500270, 15400258, 15480437, 15500490, 16040051, 16180098, 16260142, 16410196, 16500271, 15400259, 15480438, 15500491, 16040052, 16180099, 16260143, 16410197, 16500272, 15400260, 15480439, 15500492, 16040053, 16180100, 16260144, 16410198, 16500274, 15400261, 15480440, 15500493, 16040054, 16180101, 16260145, 16410199,  16500275, 15400262, 15480441, 16010001, 16040055, 16180102, 16260146, 16410200, 16500277, 15400263, 15480442, 16010002, 16040056, 16180103, 16260147, 16420201, 16500278, 15400264, 15480443, 16010003, 16040056, 16180104, 16260148, 16420202,  16500279, 15400265, 15480444, 16010004, 16040057, 16180105, 16260149, 16420203, 16500280, 15400266, 15480445, 16010005, 16040057, 16180106, 16260150, 16420204, 154000269, 15400267, 15480446, 16010006, 16040058, 16180107, 16260151, 16420205, 15400268, 15480447, 16010007, 16040058, 16180108, 16260152, 16420206, 15400270, 15480448, 16010008, 16040059, 16180109, 16260153, 16420207, 15400271, 15480449, 16010009, 16040059, 16180110, 16260154, 16420208, 15400272, 15480450, 16010010, 16040060, 16200111, 16260155, 16420209, 15400273, 15480451, 16010011, 16040060, 16200112, 16260156, 16420210, 15400274, 15480452, 16010012, 16040061, 16200113, 16260157, 16430211, 15400275, 15480453, 16010013, 16040062, 16200114, 16260158, 16430212, 15400276, 15480453, 16010014, 16040063, 16200115, 16260159, 16430213, 15400277, 15490454, 16010015, 16040064, 16200116, 16260160, 16430214, 15400278, 15490455, 16010016, 16040065, 16200117, 16260161, 16430215, 15400279, 15490456, 16010017, 16040066, 16200118, 16260162, 16430216, 15400280, 15490457, 16010018, 16040067, 16200119, 16260163, 16430217, 15400281, 15490458, 16010019, 16040068, 16200120, 16260164, 16430218, 15400282, 15490459, 16010020, 16040069, 16220121, 16260165, 16430219, 15400283, 15490460, 16020021, 16040070, 16220122, 16260166, 16430220, 15400284, 15490461, 16020022, 16040071, 16220123, 16260167, 16430221, 15400285, 15490462, 16020023, 16040072, 16220124, 16260168, 16430222, 15400286, 15490463, 16020024, 16040073, 16220125, 16260169, 16430223, 15400287, 15490464, 16020025, 16040074, 16220126, 16260170, 16430224, 15400288, 15490465, 16020026, 16040075, 16220127, 16360171, 16430225, 15410331, 15490466, 16020027, 16040076, 16220128, 16360172, 16430226, 15450374, 15490467, 16020028, 16040077, 16220129, 16360173, 16430227, 15450375, 15490468, 16020029, 16040078, 16220130, 16360174, 16430228, 15450376, 15490469, 16020030, 16040079, 16260121, 16360175, 16430229, 15450377, 15490470, 16020031, 16040080, 16260122, 16360176, 16430230, 15450378, 15490471, 16020032, 16150081, 16260123, 16360177, 16450231, 15450379, 15490472, 16020033, 16150082, 16260124, 16360178, 16450232, 15450380, 15490473, 16020034, 16150083, 16260125, 16360179, 16450233, 15450381, 15500474, 16020035, 16150084, 16260126, 16360180, 16450234, 15450383, 15500475, 16020036, 16150085, 16260127, 16360181, 16450235.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---

Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090085, 16140186, 16170284, 16250377, 16370477, 16380490, 1640181, 15510475, 16090086, 16140187, 16170285, 16250378, 16370478, 16380491, 1640182, 15510476, 16090087, 16140188, 16170286, 16260379, 16380479, 16380492, 1640183, 15510477, 16090088, 16140189, 16170287, 16260380, 16380480, 16480592, 1640184, 15510478, 16090089, 16140190, 16170288, 16260381, 16380481, 16480593, 1640185, 15510479, 16090090, 16140191, 16170289, 16260382, 16380482, 16480594, 1640186, 15510480, 16090091, 16140192, 16170290, 16260383, 16380483, 16480595, 1640187, 15510481, 16090092, 16140193, 16170291, 16260384, 16380484, 16480596, 1640188, 15510482, 16090093, 16140194, 16170292, 16260385, 16380485, 16480597, 15260015, 15510483, 16090094, 16140195, 16170293, 16260386, 16380486, 16480598, 15260016, 15510484, 16090095, 16140196, 16170294, 16260387, 16380487, 16480599, 15260018, 15510485, 16090096, 16140197, 16170295, 16260388, 16380488, 16500600, 15260020, 15510486, 16090097, 16140198, 16170296, 16260389, 16380493, 16500601, 15260022, 15510487, 16090098, 16150199, 16170297, 16260390, 16430494, 16500602, 15260023, 15510488, 16090099, 16150201, 16170298, 16260391, 16430495, 16500603, 15280038, 15510489, 16090100, 16150202, 16190299, 16260392, 16430496, 16500604, 15280044, 15510490, 16090101, 16150203, 16190300, 16260393, 16430497, 16500605, 15280046, 15510491, 16090102, 16150203, 16190301, 16260394, 16430499, 16500606, 15280048, 15510492, 16090103, 16150204, 16190302, 16260395, 16430500, 16500607, 15280049, 15510493, 16090104, 16150205, 16190303, 16260396, 16430501, 16500608, 15280052, 16010001, 16090105, 16150206, 16190304, 16260397, 16430502, 16500609, 15280053, 16010002, 16090106, 16150207, 16190305, 16260398, 16430503, 16500610, 15280054, 16010003, 16090107, 16150208, 16190306, 16260399, 16430504, 16500611, 15280055, 16010004, 16090108, 16150209, 16190307, 16260400, 16430505, 16500612, 15280056, 16010005, 16090109, 16150210, 16190308, 16260401, 16430506, 16500613, 15280060, 16010006, 16090110, 16150211, 16190309, 16260402, 16430507, 16500614, 15280061, 16010007, 16090111, 16150212, 16190310, 16260403, 16430508, 16500615, 15280062, 16010008, 16090112, 16150213, 16190311, 16260404, 16430509, 16500616, 15280063, 16010009, 16090113, 16150214, 16190312, 16260405, 16430510, 16500617, 15330199, 16010010, 16090114, 16150215, 16190313, 16260406, 16430511, 16500618, 15330200, 16010011, 16090115, 16150216, 16190314, 16260407, 16430512, 16500619, 15330201, 16010012, 16090116, 16150217, 16190315, 16260408, 16430513, 16500637, 15330202, 16010013, 16090117, 16150218, 16190316, 16350409, 16440524, 16510620, 15330203, 16020014, 16090118, 16150219, 16190317, 16350410, 16440525, 16510621, 15340206, 16020015, 16090119, 16150220, 16190318, 16350411, 16440526, 16510622, 15340207, 16020016, 16090120, 16150221, 16210319, 16350412, 16440527, 16510623, 15340208, 16020017, 16090121, 16150222, 16210320, 16350413, 16440528, 16510624, 15340209, 16020018, 16090122, 16150223, 16210321, 16350414, 16440529, 16510626, 15340211, 16020019, 16090123, 16150224, 16210322, 16350415, 16440530, 16510627, 15340212, 16020020, 16110124, 16150225, 16210323, 16350416, 16440531, 16510628, 15340213, 16020021, 16110125, 16150226, 16210324, 16350417, 16440532, 16510630, 15340214, 16020022, 16110126, 16150227, 16210325, 16350418, 16440533, 16510631, 15340215, 16020023, 16110127, 16150228, 16210326, 16350419, 16440534, 16510632, 15340216, 16020024, 16110128, 16150229, 16210327, 16350420, 16440535, 16510633, 15340217, 16020025, 16110129, 16150230, 16210328, 16350421, 16440536, 16510634, 15340218, 16020026, 16110130, 16150231, 16210329, 16350422, 16440537, 16510635, 15340219, 16020027, 16110131, 16150232, 16210330, 16350423, 16440538, 16510638, 15340220, 16020028, 16110132, 16150233, 16210331, 16350424, 16460539, 16510639, 15340221, 16020029, 16110133, 16160234, 16210332, 16350425, 16460540, 16510640, 15340222, 16020030, 16110134, 16160235, 16210333, 16350426, 16460541, 16510641, 15340223, 16020031, 16110135, 16160236, 16210334, 16350427, 16460542, 16510642, 15390363, 16020032, 16110136, 16160237, 16210335, 16350428, 16460543, 16510643, 15390366, 16020033, 16110137, 16160238, 16210336, 16360429, 16460544, 16510645, 15390368, 16020034, 16110138, 16160239, 16210337, 16360430, 16460545, 16510646, 15390369, 16020035, 16110139, 16160240, 16210338, 16360431, 16460546, 16510647, 15390370, 16020036, 16110140, 16160241, 16230322, 16360432, 16460547, 16510648, 15390371, 16020037, 16110141, 16160242, 16230323, 16360433, 16460548, 16510649, 15390372, 16020038, 16110142, 16160243, 16230324, 16360434, 16460550, 16510650, 15390373, 16040109, 16110143, 16160244, 16230325, 16360435, 16460551, 16510653, 15480434, 16050039, 16110144, 16160245, 16230326, 16360436, 16460552, 16510655, 15480435, 16050040, 16110145, 16160246, 16230327, 16360437, 16460553, 16510656, 15480436, 16050041, 16110146, 16160246, 16230328, 16360438, 16460554, 16510657, 15480437, 16050042, 16110147, 16160247, 16230339, 16360439, 16460555, 16510658, 15480438, 16050043, 16110148, 16160247, 16230340, 16360440, 16460556, 16510659, 15480438, 16050044, 16110149, 16160248, 16230341, 16360441, 16460557, 16510662, 15480439, 16050045, 16110150, 16160249, 16230342, 16360442, 16460558, 16510664, 15480440, 16050046, 16110151, 16160250, 16230343, 16360443, 16460559, 16510665, 15480441, 16050047, 16110152, 16160251, 16230344, 16360444, 16460560, 16520672, 15480442, 16050048, 16110153, 16160252, 16230345, 16360445, 16460561, 16520691, 15480443, 16050049, 16110154, 16160253, 16230346, 16360446, 16460562, 15500444, 16050050, 16110155, 16160254, 16230347, 16360447, 16460563, 15500445, 16050051, 16110156, 16160255, 16230348, 16360448, 16460564, 15500446, 16050052, 16110157, 16160256, 16230349, 16360449, 16460565, 15500447, 16050053, 16110158, 16160257, 16230350, 16360450, 16460566, 15500448, 16050054, 16140159, 16160258, 16230351, 16360451, 16460567, 15500449, 16050055, 16140160, 16160259, 16230352, 16360452, 16460568, 15500450, 16050056, 16140161, 16160260, 16230353, 16360453, 16460569, 15500451, 16050057, 16140162, 16160261, 16230354, 16360454, 16470570, 15500452, 16050058, 16140163, 16160262, 16230355, 16360455, 16470571, 15500453, 16050059, 16140164, 16160263, 16230356, 16360456, 16470572, 15500454, 16050060, 16140165, 16170264, 16230357, 16360457, 16470573,  15500455, 16050061, 16140166, 16170265, 16230358, 16360458, 16470574, 15500456, 16050062, 16140167, 16170266, 16250359, 16360459, 16470575, 15500457, 16050063, 16140168, 16170267, 16250360, 16360460, 16470576, 15500458, 16050064, 16140169, 16170268, 16250361, 16360461, 16470577, 15500459, 16050065, 16140170, 16170269, 16250362, 16360462, 16470578, 15500460, 16050066, 16140171, 16170270, 16250363, 16360463, 16470579, 15500461, 16050067, 16140172, 16170271, 16250364, 16360464, 16470580, 15500462, 16050068, 16140173, 16170272, 16250365, 16360465, 16470581, 15500463, 16050069, 16140174, 16170273, 16250366, 16360466, 16470582, 15500464, 16050070, 16140175, 16170274, 16250367, 16360467, 16470583, 15500465, 16050071, 16140176, 16170275, 16250368, 16360468, 16470584, 15500466, 16050072, 16140177, 16170276, 16250369, 16370469, 16470585, 15500467, 16050073, 16140179, 16170277, 16250370, 16370470, 16470586, 15500468, 16050074, 16140180, 16170278, 16250371, 16370471, 16470587, 15500469, 16050075, 16140181, 16170279, 16250372, 16370472, 16470588, 15500470, 16050076, 16140182, 16170280, 16250373, 16370473, 16470589, 15500471, 16050077, 16140183, 16170281, 16250374, 16370474, 16480590, 15500472, 16050078, 16140184, 16170282, 16250375, 16370475, 16480591.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502

Affected Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

Catalog Number, Manufacturing Date range, Lot Code range: (1) S2, 4/27/12 - 2/1/17, 120427X - 201702014; (2) S2-12, 4/27/12 - 3/13/17, 120427X - 201703134; (3) S2-20 MD, 4/27/12 - 1/2/17, 120427X - 201701024; (4) S2V-20, 4/27/12 - 4/7/17, 120427X - 201704074; and (5) S2V-60, 4/27/12 - 3/16/17, 120427X - 201703164

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada.

STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) || The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.

Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124; (2) S2V-20 N, 4/27/12 - 11/7/17, 120427X - 201611074; and (3) S2V-60 N, 4/27/12 - 2/13/17, 120427X - 201702134

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada.

STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) || The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.

Lot Numbers: Y011813-09, Y040612-16, Y061214-15, Y090712-04, Y012714-08, Y040715-02, Y06291501, Y091914-07, Y013012-04, Y04291601, Y072012-14, Y100412-08, Y020713-13, Y050313-10, Y072513-04,  Y103114-03, Y022814-09, Y050412-08, Y07291601, Y110912-12, Y03151701, Y050814-15, Y08031702, Y11131501, Y031715-11, Y05251701, Y081314-03, Y112414-03, Y032513-16, Y06071601, Y08231601, Y121613-07 Y03271501, Y060812-04, Y090514-11 & Y12181501.

Cardiovascular Devices

3

No

Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501.

Cardiovascular Devices

3

No

Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

Lot Numbers:  Y013114-14 Y04191607 Y061413-09 Y081513-07 Y101212-03 Y020714-08 Y04201507 Y06151504 Y081712-39 Y101413-12 Y021413-09 Y042514-10 Y061914-14 Y082212-13 Y10231528 Y021712-01 Y042712-06 Y06261516 Y08281506 Y10231529 Y030113-12 Y05041703 Y071213-13 Y090313-12 Y110714-08 Y03041604 Y05081508 Y071814-11 Y091914-13 Y112414-04 Y031414-04 Y051414-07 Y07191604 Y09241503 Y112613-03 Y032513-03 Y052914-08 Y072712-03 Y092612-16 Y112912-13 Y032612-05 Y060412-05 Y07271508 Y100212-01 Y11301601 Y040314-07 Y060713-12 Y080113-05 Y100713-02 Y121714-09 Y040813-01 Y06071704 Y081114-05 Y10071602 Y121813-09 Y041712-02

Cardiovascular Devices

3

No

Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).