Serial Numbers:  01-00106 through 01-00201

General and Plastic Surgery Devices

2

No

Nationwide

CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device || Model: CC3-01

Lot numbers: XI0017, XI0018, XI0023, XIP0043, 182, 184, 185, XIP0049, 236, 237, 239, 240, 242, 248, 249, 250, 251, 254, 256, 257, XIP0038, XIP0131, XIP0125, 3048, 3052, 3065, 3074, XI0012, XIP0143, XIP0144, XI0001, XIP0072, XI0028, XIP0061, XI0028, XI0036, XIP0074, XIP0077, XIP0082, XIP0087, XIP0132, XIP0127, XIP0124, XIP0129, XI0008, XI0029, XI0037, XI0046, XIP0123, XIP0059, XIP0107, XIP0089, XIP0096, XIP0156, XI0005, XIP0114, XI0014, XI0022, XI0015, XI0021, XI0031, XI0034, XI0024, XI0026, XIP0047, XI0042, XI0039, XIP0044, XIP0025, XIP0035, XIP0041, XIP0030, XIP0051, XIP0057, XIP0113, XIP0067, XIP0053, XIP0083, XIP0058, XIP0055, XIP0060, XIP0066, XIP0163, XIP0071, XIP0063, XIP0120, XIP0088, XIP0081, XIP0064, XIP0050, XIP0101, XIP0062, XIP0095, XIP0121, XIP0094, XIP0108, XIP0105, XIP0122, XIP0119, XIP0104, XIP0097, 104, XIP0065, XIP0164, XIP0159, XIP0152, XIP0166, XI0016, XIP0045, XIP0052, XIP0158, XIP0092, XIP0111, XIP0086, XIP0086, XIP0086, XIP0112, XIP0130, XIP0157, XIP0093, XIP0151, XIP0149, XIP0167, XIP0168, XIP0162, XIP0171, XIP0138, XIP0118

General and Plastic Surgery Devices

2

No

Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

ALL Lots - 11406, 11414, 12439, 12466, and 02521.

General and Plastic Surgery Devices

Unclassified

No

Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.

Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. || Wound Management.

Lot number: JC929332

General and Plastic Surgery Devices

2

No

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO

Lot Number: JC24165

General and Plastic Surgery Devices

2

No

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO

All lot codes

General and Plastic Surgery Devices

1

No

Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.

ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.

Product Number is 9100, Lot # 14101601.

General and Plastic Surgery Devices

1

No

Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.

American Catheter / Cholangiogram Catheter 9100 Series.

201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143

General and Plastic Surgery Devices

Unclassified

No

U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ. No foreign distribution. NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use.

ActCel || advanced bleeding control || Topical Hemostatic Dressing || 2in X 2in (5cm X 5cm) || 4in X 4in || Sterile Contents || Soluble Regenerated Cellulose || For Bleeding Control || For external topical and temporary use only || Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.

version 420343-01 and 420323-02, all lots

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.

Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. || Intended for endoscopic manipulation of tissue, including grasping.

Lot Numbers: 3035614 3046205 3052693 3055885 3063181 3068806 3073917 3082315

General and Plastic Surgery Devices

2

No

Nationwide Distribution including KY, GA, MI, and NJ.

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove || Part Number: 584569 || Ophthalmic surgical kits

149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.

SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. || Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

RPN: C-LSP-10-8; LapSac Surgical Tissue Pouch, Lot Numbers:   5723441 5623670 5551679 5385865 5101403 4499389 5150312 4872587 4701001 4573324 4475653 4475656 5083283 4994401 4475654 4349570 5647029 5189488 4592116 5222585 5466530 4678791 5128670 5647027 4960012 5239097 4976472 4898631 4763679 5371589 5578854 5184529 4696047 5443887 5512804 5578850 5138475 5495760 5316304 4351774 4310027 5202853 4617104 4892305 5754071 4956583 4803582 5689985 4757759 4736751 5739139 4861864 4861859 4828636 4522443 5047841 5010495 4536914 4717500 4408864 5252563 5065112 4939988 4678785 5301513 4706480 4939982 4872587X 4806612 5010492 4599491 4939983 4960014 4884781 5128670X 5101403X 4701001X 5047841X    RPN: C-LSP-5-2; LapSac Surgical Tissue Pouch, Lot Numbers:   F4621972 NS5273151 NS5138472 NS5047844 F4706481 NS5614093 F4803584 NS5614097 NS5189486 NS5473679 NS5451672 NS5076019 NS4983975 F4806611 F4717499 F4678774 F4544216 F4530236 F4399198 NS5647028 NS5316295 NS5202849 F4787623 F4653284 F4592117 NS5739140 F4653283 NS5032341 NS5754072 NS5578855 NS5512803 NS5443889 NS5316303 NS5164953 NS5150316 NS5057498 NS4983976 F4868019 NS5032337 F4562966 NS5032338 NS4976473 NS5239098 NS5647030 NS5578857 NS5443890 NS5189485 NS5614096 NS5301514 NS5047843 NS5670442 NS5456926 F4822785 F4612006 NS5409553 NS5409552 F4475655 NS5456925 F4884782 NS5647024 NS5385861 F4678778 NS4939987 NS5334276 NS5273150 F4811161 F4803587 NS5481611 NS5334277 F4408861 NS5614094 NS5047845 F4774686 F4373157 NS4939986 NS5551680 NS5512806 NS5495762 NS5473682 NS5443888 NS5371590 F4822786 F4604065 F4568338 NS5578856 NS5551682 NS5523837 NS5647025 NS5035754 NS5032339 NS5010496 NS5618271 NS5512805 NS5495763    RPN: C-LSP-6-4; LapSac Surgical Tissue Pouch, Lot Numbers:   4382550 5523836 4617105 4499391 4706482 4696048 5451671 5092465 5169730 5150315 5296792 5114844 5631020 5353350 5495764 5584262 4828635 4349571 4678790 4787624 4803579 4803585 4745252 5076017 4604063 4833964 4822789 4544215 4373154 4868018 4878865 5189487 4280701 4592114 4653279 4763678 4757762 4399199 5128673 5739137 4898632 4511698 4678783 4363194 5431770 5456924 4300816 4530235 4434818 5316300 5239099 4969714 4916260 4639428 5047846 4939993 4562964 5647026 5393323 5316300X 5551683 5723440 4678775 4926134 5602131 5614098 5202855 5723438 5723443    RPN: C-LSP-8-5; LapSac Surgical Tissue Pouch, Lot Numbers:   5602135 5647023 5495761 5343041 5393322 5296793 5114846 4757764 4599492 5551681 5114842 4828634 4310025 4382554 4592115 5466528 5431771 5316301 5316302 5138471 5035755 4939990 4562965 4337889 5784206 5578858 5065111 4956587 4906789 4530237 5481612 4892306 4639430 4573323 4511699 4351775 4653280 5169733 5578853 5512807 4994403 5010498 4803586 4966364 4475658 4434813 4701002 4939984 5189489 5138476 5252564 4434810 5189483 5623671 4451573 4399200 4621973 4717501 5150317 4969713 4822787 4503779 4283109 4678786 5083284 4678792 4868021 4678779 4701002X 5316301X 4803580 4811162 F4373155 F4475657 F4408862 NS5296795 4745253    RPN: C-LSP-10-8-INTRO; LapSac Pre-Loaded Surgical Tissue Pouch Introducer, Lot Numbers:   NS5710551 NS5547708 NS5511499 NS5062538 NS5011845 NS5046145 F4560845 NS5278269 F4807112 F4500284 F4700169 NS5080719 F4568860 F4510597 NS5152758 NS5398797 NS5058279 F4832544 F4564052 NS5334897 NS5143089 F4903162 F4679606 NS5233934 NS5395130 NS5244335 NS5244304 F4700183 NS4998648 NS5437313 NS5005951 F4552428 NS5693809 NS5410812 F4572449 F4335687 NS5525413 NS5452661 NS5387436 NS5347777 NS5214342 NS5181485 F4785955 NS5039099 F4412737 F4327739 NS5119680 NS5042655 NS4954679 F4871918 F4564062 F4560835 F4488998 F4558683 F4857903 NS5380368 NS4960919 F4778319 F4566291 NS5133441 NS4998611 NS4977761 NS5171345 NS5244349 NS5152734 NS5112351 NS5102853 F4491814 NS5205060 F4643285 NS4930514 F4651659 NS5136821 NS5136814 F4355906 NS5119678 NS4998615 NS5478778 F4694145 F4648441 NS5175744 F4324757 NS5765457 F4844521 F4743691 NS5102890 F4564058 NS5621333 F4510577 F4319688 NS5181491 F4705166 F4702571 NS5298895 F4525628 F4483897 NS5619311 NS5263649 F4809759 F4729214 F4706998 F4651637 F4542980 NS5562666 NS5603165 NS5410816    RPN: C-LSP-8-5-INTRO; LapSac Pre-Loaded Surgical Tissue Pouch Introducer, Lot Numbers:   NS5710553 NS5368699 NS4991871 F4630673 F4483899 NS5062540 F4832554 F4515467 NS5133449 NS5491398 NS5376756 NS5758782 F4700181 NS4998650 NS4930516 NS5517550 F4428206 NS5727299 F4765125 NS5062542 NS5421805 F4696845 F4661304 F4591087 F4495716 F4407089 F4397403 F4714371 F4707033 F4664803 F4654900 NS5449121 NS5015410 NS5537338 NS5533948 NS5525388 NS5514397 NS5495081 F4922747 F4630669 F4394607 NS5195344 NS5517548 F4709210 F4330946 F4474134 NS5517528 NS5087792 NS5087784 NS5340761 NS5768703 NS5745235 NS5727307 NS5718041 NS5559748 NS5331982 NS5594142 F4726298 NS5748939 NS5241079 F4891589 F4849861 F4857901 NS5380376 NS5368701 NS5347761 NS5755708 NS5752054 NS5736990 NS5459380 F4688601 F4669628 NS5758770 NS5748927 NS5733395 NS5727297 NS5724520 NS5720902 NS5718022 NS5475652 NS5471645 NS5467732 NS5463195 F4423068 NS5105731 NS5733405 NS5119682 NS4998613 F4705170 F4702569 F4593619 F4720688 NS5463197 F4915356 NS5562668 NS5603163 NS5569211 NS5410814    RPN: J-LS-050200; LapSac Tissue Entrapment Pouch, Lot Numbers:   U2339308 U2256858 U2208253 5012361 U2262840 U2262839 U2223605 4937727 5366852 5089340 UF2297233 UF2390345 UF2347198 NS5229106 U2478872    RPN: J-LS-050201; LapSac Tissue Entrapment Pouch, Lot Numbers:   5290994 5376288 5196287 5503085 5613803 5301279 5332614 U2168993 U2359401 U2434183 U2313145 U2215663 U2195680 5557632 5674626 U2408995 U2256962 U2316441 U2393785 U2268257 U2279502 U2209182 U2164716 U2306776 U2203204 U2349401 U2438500 U2441609 U2367869 U2325869 U2463292 U2418182 U2293326 U2221162 4976506 U2245850 U2388625 U2402651 U2181160 4945207 U2288465 U2230960 U2336501 5690726 U2276641 U2476987 U2484481 U2469344 U2240076 5150209 U2282290 5183372 U2435077 U2274360 5363454 U2182876 5340316 U2425452 5072609 U2445610 U2347789 5810624 U2486353 U2392697 5054746 5376289 5673856 5288346 5353109 4945213 U2271956 U2419912 U2158039 U2365632 NS5303494 5288192 U2353450 U2215198 5407025 U2378148 U2193444 U2241016 U2282977 U2307461 U2256954 U2330401 U2284423 U2443585 U2435561 5131920 5308120 5506398 U2234418 U2210278 U2457839 U2227304 U2398530 5057269 5527433 U2371115 5202915 U2198319 U2280511 U2462586 U2481534 5121368 U2226743 U2343931 U2246687 U2172064 4996992 5057270 U2266194 5643271 NS4954243 U2408990 U2435087 U2215661 U2408996 U2369737 UF2158692 U2430591 U2217473 UF2215674 U2318439 U2385130 U2420334 U2380786 U2334042 U2361796 5766814     RPN: J-LS-050202; LapSac Tissue Entrapment Pouch, Lot Numbers:   U2455228 U2164302 U2231386 U2221161 U2182871 U2233773 U2260629 U2347196 UF2243035 NS5787084 UF2182878 UF2261190 NS5636253 NS5803367 NS5017119 UF2451636 UF2462587 NS5760929 U2323284 U2212729 UF2426752 UF2456379 NS5477234 U2205220 U2280512 U2345063 UF2456378    RPN: J-LS-060401; LapSac Tissue Entrapment Pouch, Lot Numbers:    5447239 5501887 5649734 5649736 5650732 U2437234 U2366056 U2171502 U2198758 U2485353 4941174 U2187883 U2207190 5677023 U2325870 U2163241 U2203764 5407026 U2487571 U2367870 U2167288 5376290 5229104 5662035 5613804 5630037 5473829 5381357 5318092X 5318092 U2262366 U2273561 U2223606 U2321791 U2423286 U2355896 U2333285 U2344475 U2256957 5172220 U2445974 U2189481 U2276649 U2265388 U2337371 U2269311 U2245848 U2252956 U2248615 U2219303 U2211794 U2468705 U2465509 U2185146 U2419913 U2308559 U2298888 U2445612 U2381815 5003499 5695190 5673857 5488829 5635793 U2393786 U2408997 U2427867 5176708 U2474822 U2302103 U2159746 U2435551 U2400765 U2385722 U2374010 U2287238 5371833 5363455 5353108 U2378681 U2246355 5125075 U2282978 U2313147 5252020 U2195681 U2441610 5659716 U2329187 5057271 5646046 5017120 U2431629 U2460352 4983106 5232195 U2288466 U2236541 U2226751 5202920 5154709 5036141 U2343932 U2216378 5810625 UF2429147 5232196 U2330402 U2396842 U2353452 U2418183 U2354113 U2227310 U2426753 U2391067 5620437 U2347916 U2389709 U2179702 U2420553 5131923 5754386 U2352160 U2408991 U2466766 5407027 5630041 U2260632 NS4954244 U2230958 5161150 U2280513 5396322 U2430596 U2315964 U2366060 U2226745 U2406774 U2339310 5371834 U2290329 U2264087 U2343933 5104406 5118008 5288347 U2358754 U2277855 U2264089 U2188348 U2196275 U2365027 5381353 U2288467 U2422101 U2218800 4945214 U2172066 5677025 U2365633 5292777X U2238257 U2356816 U2468709 U2276650 U2231474 U2258697 U2191251 5292777 5392282X U2371039 5527434 U2195679 5375074 U2236541S 5363458 U2306778 U2184681 U2251865 U2172543 U2358025 5724049 U2241746 U2219028 5814133 U2245849 U2234420 U2213371 U2177421 U2191245 5423472 5766815 U2213369 U2329193 5695191 5757308 U2330403 U2255277 U2471755 U2458256 5196288 U2182880 U2316446 U2408998 5620436 U2363099 U2174503 U2237763 U2311999 U2420554 U2281039 U2261191 U2435081 5807052 U2480366S U2273563 5086045 U2232471 U2314208 U2308556 U2287245 U2315965 5716390 U2375656 U2380302 U2481537 5118010 5125077 5466143 5385573 5010513 U2322274 5040107 U2188349 U2196274 U2193445 U2345065 U2223192 U2172067 U2264090 U2419914 UF2370446 U2476055 U2164721 5292778 5486095 5545023 U2170085 5412741 5501888 5057273 U2386804 U2254675 U2412603 4945209 U2305106 5176709 U2448784 5252022 U2310437 U2311529 U2192730 U2306777 U2256955 5215521 5423473 5766812 U2377625 U2369153 5320759 5477235 U2219025 5757309 U2482359 5068441 U2440971 U2405568 5318093 5754388 U2231893 U2451637 U2268699 UF2431628 U2318440 U2431627 U2355897 U2443584 5196289 U2435088 U2435562 U2174502 U2273564 U2229843 5290995 U2486356 U2284424 5392282 U2349402 U2171003 U2316882 4987116 5649738 U2273562 U2308560 5347078 U2203205 U2423887 U2260630 U2303626 5567781 U2287244 U2215668 U2293321 U2249324 5664390 5506399 5732653 U2490247 5125076 5673855 5671154 5099563 U2370443 U2483184 5403891 U2271957 U2432725 5409245 UF2185728 5363456 4954245 U2158038 5121373 5451448 U2182872 U2432286 U2463293 U2365029 U2170086 U2350618 U2238253 U2322760 U2435552 5057272 U2254676 4945208 U2181159 U2199788 U2214487 U2331445 U2478256 5252021 5000589 U2391655 U2405567 5592544 U2282979 U2177427 5215520 5484975 U2287812 U2413141 5068439 5766813 U2262857 U2346757 U2207735 U2268698 U2396841 U2452117 U2318441 5407028 U2166762 U2183465 U2479498 U2282295 U2215199 U2320158 U2229842 U2259262 U2327529 4983109 U2349403 U2316883 U2198756 4976507 U2457840 5630042 U2372217 U2381819 5564463 5807056 4950734 U2466765 U2249323 5506396 U2190027 U2277320 5567780 U2279503 UF2353451 5113483 U2302102 5054744 5110703 5347077 U2325871 U2330395 5332615 U2166139 U2292020 U2465507 U2386246 5099562 5017121 U2432726 U2196272 U2299978 U2246688 U2408244 U2352737 5420019 U2297234 U2228767 U2418177 U2166758 5650733 5814142 NS5764107 U2260099 U2290330 5376291 U2480366 U2260097 U2365030 U2187368 U2343926 U2425457 U2199789 U2205738 U2336503 U2367872 U2331444 U2184684 U2276648 5138994 U2482359S U2350617 U2385138 U2238258 U2242542 U2185727 5598445 5630038 U2177426 5484976 5423471 U2469349 U2369151 U2454625 5477237 U2435557 5423471X U2473014 U2363521 U2396846 U2261186 U2214482 U2255274 5539312 U2318442 U2166763 U2449364 U2452118 5825409 U2361798 U2224548 5595513 U2340452 4972380 5807051 U2179700 U2456380 5003500 U2198757 U2314207 4983110 U2279504 U2178974 5716399 U2166134 U2339309 U2369738 U2319121 5086046 U2232472 U2373383 U2437236 U2199455 U2455230 4950739 5296396 5466134 5709036 U2270948 U2419687 UF2380301 U2455229 U2393787 U2465508 U2234419 U2359404 U2186826 U2210279 U2390346 5040108 5601866 U2246689 U2408245 U2383879 U2370447 U2240590 5125067 5154707 U2411436 U2398531 5503086 U2210280 5036142 5522469 U2189480 5492463 U2423287 5650734 5522470 U2258691 U2343925 U2300884 U2364265 U2376316 U2416020 U2336502 U2367871 5138995 5787083 5738336 U2364263 5506400 U2185726 U2209734 U2310432 U2361023 4996996 5477236 U2191247 U2289052 U2396847 5831691 U2214481 U2219026 U2431622 5168436 5068442 5232197 U2473011 U2163823 U2324689 U2409478 U2244089 U2485354 U2215667 U2179701 5003501 U2164719 U2325238 U2379408 U2426754 U2387920 U2369739 5784004 5161155 U2174911 5506390 U2235335 4950738 U2371040 U2445975 U2460026 UF2158694 U2460353 5732654 5496030 U2473502 U2226742 5193592 U2230957 U2406773 U2171286 5764106 U2256963 U2483187 5332611 U2408242 U2400766 U2374696 5099566 U2277856 U2412119 U2303136 U2172065 5677024 U2208258 5340317 5036143 5288348 5371837 5716400 U2191250 U2342517 5527435 5795491 U2474823 U2251864 U2358024 U2170076 5145394 5202921 U2445615 U2307462 U2327530 UF2422100 U2304660 U2337370 U2218799 U2367865 UF2387919 5831690 U2214480 U2219027 U2435553 5738327 NS5650731 NS5650727 NS5650729 NS5650730 NS5650726 NS5650728 5560884 5595512 NS5375072 NS5375073    RPN: J-LS-080500; LapSac Tissue Entrapment Pouch, Lot Numbers:   5466144 5646047 U2303625 5047556 U2177428 5125068 U2401537 U2392698 U2340453 U2330992 U2319125 U2406775 4950735 U2396848 U2225137 U2316442 U2222894 U2166764 U2476990 5099567 U2426755 5412742 U2329188 U2199456 U2452110 U2455231 5375075 U2380303 U2374697 U2365033 5662039 5649735 5613805 5649737 5545026 5501882 5385574 5363453 5363457 5353107 5172221 5138999 5068443 U2473015 U2445971 U2449365 U2420555 U2416024 U2412120 U2386247 U2354114 U2361800 U2369156 U2347917 U2305107 U2292021 U2276651 U2252957 U2264922 U2261192 U2241017 U2232473 U2227308 U2207736 U2195682 U2179902 U2182882 U2164303 U2161747 U2156353 5215518 U2220506 5509549 5560885 U2273557 U2300885 U2297235 U2210282 4972381 5654678 U2192731 5003502 U2255278 U2249315 5630047 U2465510 U2422639 5650739 U2440977 U2330396 U2460354 U2189484 U2286597 5677026 U2358026 U2211795 U2217481 5447236 U2490248 5017122 5232198 U2306779 U2466767 U2437235 U2479499 U2275188 U2268700 U2244090 U2187882 5695192 U2435554 5332616 U2487575 U2258698 U2346421 U2469768 U2325874 U2483188 U2170087 U2237148 U2309943 5527429 U2434184 U2203206 U2288471 U2343937 U2440977S U2173928 U2335163 U2229272 U2229272S 5308121 5327959 U2455732 5161156 U2244091 U2235336 U2198759 5040113 U2187371 U2166140 U2418178 U2354109 5501883 U2303137 U2264091 U2396309 5057274 5738338 U2469766 5724050 U2170088 U2327531 U2252951 5215522 5814135 U2367866 5831693 U2292019 U2181863 5243122 5613806 U2396849 U2441611 5650740 U2200602 U2435563 U2351249 5003503 5142016 U2426756 UF2213373 5347079 5128273 U2380304 U2309265 U2302104 U2188350 U2474110 U2274361 U2408246 5466145 U2370448 U2463294 5492464 U2191252 U2172544 U2425453 U2488248 U2219029 U2213372 5028393 5407029 U2482357 U2471756 U2479500 5595515 U2379405 UF2213374 5664396 U2315966 5716391 5176710 5803366 U2419919 U2488833 U2256964 UF2215669 5040106 5792523 U2313153 5092089 5292780 5371838 5125065 5674627 U2241018 U2414727 U2205739 U2367873 5477238 U2214479 5318094 5389970 U2255275 U2355898 U2435089 U2261193 U2255279 U2392700 U2279505 U2308554 U2309944 5296397 U2229838 U2234412 U2314211 U2460355 U2249316 U2468706 U2412121 5381354 U2375083 U2251203 U2210281 U2196714S 5154708 U2254677 U2470947 5068438 U2204749 U2181866 U2166765 U2329194 U2369157 U2196712 U2330404 U2196714 NS5744755 U2174504 U2185145 U2340925 5139000 U2232474 4976504 U2287246 5054745 U2215670 U2432727 U2299979 U2455225 U2277857 5125078 UF2215675 U2161746 U2208259 5825410 U2191246S U2311522 U2385139 U2358027 U2252953 5551903 U2318443 U2219030 U2361799 U2164717 U2227311 5232199 U2323285 U2456381 5757310 5131924 U2315958 4983115 5620438 5113481 U2270949 5396323 U2430597 U2392699 5332617 U2343938 U2325875 5000590 5503087 U2158695 5161156X 5522471 U2268701 U2376317 U2331446 U2449366 5097095 U2163824 U2185729 U2285632 U2252952 5208300 U2191246 UF2176382 U2473016 U2306257 5168437 NS5650738 NS5650737 5595514 5581472 5292779    RPN: J-LS-081000; LapSac Tissue Entrapment Pouch, Lot Numbers:    5667655 U2278231 U2413142 5139001 U2422635 4983108 U2319126 U2193446 5403900 5301287 U2224114 5099560 U2168994 U2177422 U2430598 U2298348 5473818 U2345066 U2203207 U2315961 U2161748 U2330397 5012362 5447240 5692343 5564461 U2460356 U2452111 U2468710 U2377626 U2419688 U2392701 U2361024 U2262367 U2244806 U2218802 U2369160 5716439 5215523 5072610 5613807 5290516 5118011 5527430 4963457 U2488834 U2208260 5366853 U2486354 U2358755 U2357255 U2229844 U2236542 U2275189 U2287239 U2441612 U2398532 U2269317 U2187884 U2256965 5501889 U2476057 U2310438 U2305805 U2249814 5196283 5040116 U2339311 U2351250 5243121 U2376987 U2323286 5296398 U2314212 U2221739 U2478873 U2196713S 5376292 U2204750 U2295080 U2218796 UF2476056 NS5161157 UF2451640 UF2485357 U2285630 5473819 U2458257 4950733 5104404 U2264921 U2488249 U2409476 5158091 U2229844S 5496025 5212950 U2248821 U2436291 U2374005 U2255280 U2472421 5567779 U2340454 U2317349 NS5047558 UF2485358 U2473503 U2231468 U2277319 5057276 U2196713 U2359877 U2236539 NS5057275 U2393788      RPN: J-LSI-102500; LapSac Tissue Entrapment Pouch Introducer, Lot Numbers: NS4993649; NS5439526; NS5068444; NS5145395; NS5423474; UF2481538; NS5257887; NS4966724; UF2282980; NS5477239; NS4945215; NS5054749; NS5012363; NS5835007; NS5047552; NS5104411;UF2385140; NS5125079; UF2305806; UF2177429; U2329185; UF2227312; U2188351; U2198760; UF2476058; UF2343942; UF2287247; UF2214488; 5104405; U2375081; UF2241019; UF2456382; 5007451; UF2422102; UF2451641; U2264380; 5003494; NS4941176; U2248820; NS5079143; U2361793; NS5229110; UF2301499; UF2463295; U2310433; UF2438497; UF2174505; NS5296399; NS5252016; U2434182; U2481067; UF2282296 RPN: 054601; LapSac Surgical Tissue Pouch, Lot Numbers:   5683680 5007450 5407023 5223476 U2337366 5466137 5186543 U2448208 U2310436 U2164718 U2389228 U2396311 5363460 U2484475 U2288463 U2472423 U2461588 U2431625 U2491399 U2425456 5522465 U2171002 U2177935 5605210 U2351246 U2194990 U2212350 U2374009 U2456376 U2385131 U2346754 U2314805 U2417574 U2403361 U2273558 U2368618 U2231472 U2218798 U2441606 U2297230 5301282 5057265 U2266193 5754387 U2330400 U2184683 U2248103 U2297230S U2204745 U2170073 5099565 U2273558S U2361019 U2321789 U2449952 U2294738 UF2435556 U2272484 5466138 NS5193598 NS5359928 4941173 5332610 4979969X 5057264 5795487 U2439233 U2325867 5506392 U2372215 U2392691 U2221740 5252019 5332613 5716396 NS5010511 U2385136 UF2204746 U2476051 U2241009 U2454623 UF2205746 U2427865 UF2259260 U2223603 5601862 U2352736 U2303133 U2205733 U2172541 U2350614 U2191243 U2491404 5196280 U2329186 UF2458834 U2265387 U2340447 U2243031 5732652 5193590 NS4966716 U2212728 5409244 UF2364264 NS5121371 U2269307 U2256953 U2335930 UF2429145 4979969 UF2251863 5620435 UF2368619 5007449 U2416017 4972378 NS5290991 U2205219 U2249811 UF2357257 5104402 5664386 5288345 U2462025 NS5142019 5795489 U2306770 5539311 U2447605 U2438499 5327958 U2479494 NS5359929 U2188347 NS5142018 5481671 U2360410 U2213736 U2431625S    RPN: 054100; LapSac Tissue Pouch, Lot Numbers:   5172222 5385575 5028394 5003496 5664387 5477231 5340312 5284080 5121367 5202918 U2435091 5501884 U2488250 U2321786 U2318435 U2327525 U2262854 U2251862 U2234414 5412743 5145390 5131921 U2469343 U2388624 U2374008 U2358753 U2346753 U2354110 U2343543 U2305109 U2288462 U2330398 U2390343 5186542 U2452112 U2385720 U2277851 5738330 5635794 5320758 5303492 U2466763 U2441605 U2417575 U2396844 U2378150 U2363097 U2213737 U2369736 U2479497 U2472422 U2178971 5363459 5539310 U2448207 U2182475 U2193677 5716394 5057263 4954242 U2380787 U2335158 U2324683 U2314206 U2241013 U2220503 U2166757 U2444965 U2392243 U2491403 U2429144 U2215664 U2276642 U2227305 U2197523 U2211792 U2158689 U2481535 U2350612 5439527 U2456375 U2426088 U2420550 U2337364 U2309264 U2298890 U2267017 U2238254 U2207739 U2255811 5595509 U2405565 U2176381 5376284 5567778 5232192 U2190029 U2173013 U2412117 U2170081 U2229839 U2261187 5089342 5683681 U2185724 U2164306 U2365635 U2205736 U2440972 U2246356 U2203202 U2293325 U2271952 5513357 4979971 U2227305S U2205736S U2215664S U2261187S 5662036 U2473010 U2458255 U2215662 5466136 U2394893 U2488829 5601864 NS5359926 U2217472 NS5290989 5000591 5545024 U2161740 U2164305 U2386803 5584240 5323381 5705610 U2369152 U2452113 5232191 U2376986 UF2441604 5284075 U2340041 U2359875 U2183936 4972377 U2445973 UF2451632 U2450415 5803365 U2464263 U2401536 U2249812 U2267593 5677022 5292776 U2238252 U2350613 U2240589 5527431 5814132 5711905 5375069 U2351244 U2255276 5089343 U2323282 U2340448 5161152 U2232468 U2210275 U2318436 5193591 U2408989 U2422636 5031514 NS5142017 U2170080 U2211273 U2285631 5477232 5814137 U2329191 U2295082 U2454622 U2246357 U2196711 UF2218797 U2215665 U2439784 5252008 5086049 U2392695 NS5183790 U2300388 U2277852 NS5086048 U2221736 U2432720 U2282291S U2477631 5486097 U2290326 5560883 5318085 UF2480363 U2435559 5318089 U2182869 U2440973 4950741 5168435 U2327526 U2451633 U2259259 U2379407 5646048 4979970 U2315957 U2359876 5564462 U2296365 5506391 5392276 5347076 U2430594 U2203199 5193593 5385576 U2249313 U2193442 U2271953 U2188346 U2375082 5486096 U2414729 5007448X U2238255 U2260096 U2478254 5229105 U2322757 U2256952 U2266192 U2187881 U2470249 5766817 U2162798 U2470250 4950742 U2363520 5635791 U2166760 U2229840 U2285629 U2486355 U2427866 U2282291 5007448 U2369152S U2412115 U2432719 U2330399 5409246 NS5359927 5403892 U2419910 U2205745 4954246 U2410045 5075542 5121370 U2305110 U2463288 NS5738329 U2335159 U2405562 U2360409 U2177424 U2306773 5787086 U2469765 5738331 U2310435 U2379912 U2445613 U2336499    RPN: 054800; LapSac Surgical Tissue Pouch, Lot Numbers:   5689042 5385577 5340314 5290515 5243123 5212952 5057266 5125066 5290992 5766816 5716397 5595510 U2472425 4950736 5003498 U2311525 U2469347 5503082 5145391 4945206 U2491400 U2383215 U2389708 5409247 U2480365 U2422097 U2369740 U2350615 U2376315 U2324684 U2217475 5664388 U2400763 U2366058 U2214484 U2487574 U2176934 U2181864 U2168378 U2221737 U2210277 U2205737 U2199787 U2164304 U2194987 U2243032 5527436 5068440 U2436293 U2405566 U2452114 U2183938 5363461 5466139 U2354108 U2319532 U2238256 U2187373 5196282 U2171501 U2460351 U2418180 U2387917 U2282292 U2269308 U2249314 5110702 U2231469 5466139X 5557635 U2359403 U2231469S U2337367 U2300881 U2254255 U2247185 5522468 5630040 5017116 U2456377 U2408994 U2356433 U2343929 U2296369 U2305111 U2426750 5427947 5375070 5138991 U2258696 U2392696 U2347788 U2484478 U2160445 U2441607 U2415407 U2315963 U2288464 U2261748 U2224545 U2273559 5202919 5036138 U2476052 U2378151 U2234415 U2210277S U2192268 4966318 U2448209 4987114 U2396845 U2445614 U2331440 U2203203 5486098 5303498 U2431626 U2267018 U2199787S U2176934S U2383215S U2249314S U2305111S U2171501S 5506393 U2461589 NS5099561 U2411434 UF2267594 UF2489828 U2291632 5246210 NS5643269 U2170084 UF2204747 U2322759 U2311526 5072607 U2282975 U2364261 UF2301501 U2273556 U2311526S 5196284 UF2378152 NS5771568 U2435092 U2284421 UF2246685 U2221738 5371835 5601863 5363462 5439524 U2161743 5121372 5527426 UF2204747S NS5359930 U2322758 U2185725 UF2431624 U2289051 U2377623 U2422098 5659715 NS5296580 5654676 U2341932 UF2378152S 5292775 UF2249321 U2170075 NS5434798 UF2258695 U2440974 5292775X 5757302 U2397470 U2237147 5407024 5168438 5643267 U2475415 5284079 U2400318 UF2259261 U2280510 5104403 U2408988 U2228761 U2311521 5301283 U2366059 UF2262855 U2207734 5158090 5196281 NS5168439 UF2349397 U2173438 U2201184 U2244805 U2171001 U2183935 5473825 5284078 NS5017118 U2410600 5673853 UF2351247 U2333286 UF2297228 5531053 U2260098 NS5176707 UF2361020 5770788 U2383216 U2350616 U2385717 U2454624 UF2480364 U2292015 5662037 5646049 5620434 U2275088 U2408986 5439528 UF2354111 U2437841 U2170083 UF2483186 NS4950743 U2158686 5592543 U2220504 U2491401    RPN: 054200; LapSac Tissue Pouch, Lot Numbers:   U2335157 U2365636 U2359402 U2308558 U2222221 UF2321788 U2319531 U2206240 U2209181 U2330991 U2213735 NS5588583 NS5513358 NS5716395 NS5690725 NS5711906 U2351245 NS5290990 UF2390344 NS5506389 NS5630039 NS5757304    RPN: 054201; LapSac Tissue Pouch, Lot Numbers:   U2468708 U2244088 U2309942 U2276645 U2254678 U2269305 U2178972 U2287811 U2294737 U2217474 5040109 U2190028 4979972 5522467 5654677 U2443942 U2456816 U2398528 U2230959 U2316443 5477233 U2158690 U2210767 U2204744 U2194312 5588584 5303497 5125071 U2390341 5401129 5290514 5089344 U2484476 U2430142 U2435555 U2416019 U2387916 U2337365 U2375654 U2366057 U2353448 U2324688 U2260631 5771567 5212949 U2170082 U2392692 U2486888 U2450974 U2232469 5396321 U2226744 U2424530 U2242539 U2191248 U2308555 U2481536 U2187369 U2269306 U2368615 U2449951 U2362393 5673854 U2455224 U2206241 5020477 UF2368617 5113482 U2277849 U2252955 U2226342 NS5017117 U2394894 U2277850 U2264088    RPN: 054202; LapSac Tissue Pouch, Lot Numbers:   UF2173927 UF2385721 UF2210276 UF2209732 UF2342516

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (nationwide) including PR and to the states of: AZ, AK, AL, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, ME, MT, NC, ND, NE, NH, NJ, NY, NM, OH,OK,OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and to the countries of : China, Korea, Denmark, Mexico, New Zealand, India and Colombia.

LapSac Surgical Tissue Pouch. || The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

Lot Numbers: 1092289, 1092288, 1092287, 1092284, 1092276, 1085237 (Expiration date: 09JAN2017)

General and Plastic Surgery Devices

2

No

US Nationwide Distribution

EVAC 70 XTRA with Integrated Cable REF EICA5872-01 || Product Usage: || PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.

Lot Numbers: 1092290, 1092291, 1092292

General and Plastic Surgery Devices

2

No

US Nationwide Distribution

PROcise XP Wand with Integrated Cable REF EICA8872-01 || Product Usage: || PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.

Lot Numbers:  3038787 3046210 3061080 3078492 3093681 3095940 3108668

General and Plastic Surgery Devices

2

No

Nationwide Distribution including KY, GA, MI, and NJ.

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove || Part Number: 584648 || Ophthalmic surgical kits

Lot Numbers:  3039720 3046211 3047770 3049473 3070763 3082330 3089827 3093682 3095941 3106407 3117874

General and Plastic Surgery Devices

2

No

Nationwide Distribution including KY, GA, MI, and NJ.

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove || Part Number: 584649 || Ophthalmic surgical kits

Lot Numbers:  3045852 3053258 3063193 3068829

General and Plastic Surgery Devices

2

No

Nationwide Distribution including KY, GA, MI, and NJ.

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove || Part Number: 584671 || Ophthalmic surgical kits

Lot Numbers:  3068113 3078510 3086351 3089841 3096796

General and Plastic Surgery Devices

2

No

Nationwide Distribution including KY, GA, MI, and NJ.

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove || Part Number: 584676 || Ophthalmic surgical kits

Part Number: 0010-9400. Serial numbers: AMVM01, AMVM06, AMVM07, AMVG01, AMVP05, AMVP07, AMVP13, AMVS05, AMVK02, AMVS03, AMVS07, AMVE01, AMVS06, AMVP03, AMVS08. AMVS09, AMVS10, AMVS11, AMVS12, AMVM04, AMVM08, AMVM09, AMVM05, AMVS02, AMVK05, AMVP10, AMVS11, AMVP12, AMVP14, AMVP15, AMVP16, AMVP17, AMVP18. AMVS01, AMVK01, AMVK03, AMVK04, AMVK06, AMVK07, AMVK08, AMVK09, AMVK10, AMVM02, AMVM03, AMVM10, AMVP01, AMVP02, AMVP04, AMVP06, AMVP08, AMVP09, AMVS04.

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.

StoneLight 30 Laser System (NS3000). || For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.

Dual Arm: Part #569710902 - Serial Numbers: 15664, 15672 thru 15673, 15738 thru 15739, 15791, 15803, 15818 thru 15819, 15822 thru 15823, 15830, 15834 thru 15835, 15881, 15889, 15981, 16016, 16019, 16058 thru 16064, 16066 thru 16067, 16120, 16284, 16286 thru 16287, 20076 thru 20077, 20142, 20151 thru 20152, 20155 thru 20157, 20193 thru 20194, 20216 thru 20220, 20249, 20256, 20258, 20263, 20270 thru 20271, 20277, 20292, 20300 thru 20301, 20304, 20337 thru 20338, 20342 thru 20343, 20350, 20464, 20504 thru 20506, 20508 thru 20511, 20523, 40002 thru 40003, 40014 thru 40015, 40031 thru 40032 and 40034.  Part #567910904 - Serial Numbers: 13177, 13190 thru 13191, 13204, 13208, 13217, 13219 thru 13220, 13232, 13235 thru 13236, 13249, 13251 thru 13252, 13254 thru 13255, 13257 thru 13260, 13288, 20004, 20008, 20061, 20063, 20065 thru 20072, 20111 thru 20115, 20119 thru 20120, 20122, 40001 thru 40002 and 40011 thru 40013.  Part #567910906 - Serial Numbers: 14509 thru 14510, 20014, 20085, 20091, 20097, 20101 thru 20104, 20114 thru 20115, 20231, 20246 and 40016 thru 40017.  Part #567910913 - Serial Numbers:12353 thru 12370, 12381, 12391 thru 12394, 20000 thru 20004, 20013, 20019 thru 20020, 20028 thru 20029, 20031, 20043 thru 20201, 20131 thru 20133, 20144 thru 20151, 20154 thru 20155, 20161, 40005, 40007 thru 40008 and 40018 thru 40020.  Part #567910915 - Serial Numbers: 12646, 12648 thru 12652, 20026 thru 20027 and 40007.  Part #567910923 - Serial Numbers: 12908, 20009 thru 20014 and 20022 thru 20023.  Part #567910936 - Serial Numbers: 12150 thru 12152.  Part #567910938 - Serial Numbers: 12067, 20007 thru 20011 and 40000.  Part #567910957 - Serial Numbers: 12295 thru 12296, 12304, 12310, 12312, 12347, 12356 thru 12360, 12409 thru 12410, 12416, 20011, 20015 thru 20016, 20018, 20028, 20035, 20041, 20063, 20070, 40007 and 40009.  Part #567910958 - Serial Numbers: 12254 thru 12263, 12273 thru 12275, 20010 thru 20011 and 40001.  Part #567910961 - Serial Numbers: 12386 thru 12389, 12393, 12420 thru 12421, 12426 thru 12429, 12470, 12476 thru 12477, 12481 thru 12483, 12514, 12551 thru 12553, 12560, 20002, 20023, 20045 thru 20046, 20048 thru 20051, 20053, 20055 thru 20057, 20062, 20065 thru 20066, 20068 thru 20071, 20073, 20081, 20084 thru 20093, 20120, 20121, 20123 thru 20127, 20138, 20202, 20206, 20214 thru 20215, 20217 thru 20221, 20223 thru 20225, 20229, 40006 thru 40007, 40023 and 40049.  Part #567910964 - Serial Numbers: 12179 thru 12197, 12199, 12202 thru 12209, 20001 thru 20006, 20029, 20033 thru 20050, 20052 thru 20063, 20085 thru 20087, 40000 and 40002 thru 40003.  Part #567910968 - Serial Numbers: 12054 thru 12060, 20004 thru 20008, 20012 thru 20018, 20023 thru 20028, 20044 and 40002 thru 40005.  Part #567910970 - Serial Numbers: 12026 thru 12029, 12031 thru 12033, 12039 thru 12040 and 20005.  Part #567910971 - Serial Numbers: 12178, 12194, 12196, 12198 thru 12201, 12204, 12207, 12210 thru 12211, 20000 thru 20002, 20005 thru 20008, 20019 thru 20020, 20022 thru 20025, 20032 thru 20040, 20043, 20048 thru 20050, 20056 thru 20061, 20063 thru 20067, 20071 thru 20073, 20079, 20083 thru 20085, 20090 thru 20104, 20119, 20125 thru 20129, 40007 thru 40010, 40012 and 40019 thru 40022.  Part #567910986 - Serial Numbers: 10000, 10021 thru 10035, 20000 thru 20002 and 40000 thru 40004.  Part #567910990 - Serial Numbers: 40026 thru 40028.  Part #567910993 - Serial Number: 30005.  Part #567912907 - Serial Numbers: 10023, 10027, 20006 and 40001.  Part #567912908 - Serial Numbers: 10002, 10011, 20000 thru 20003 and 40000.  Part #567912909 - Serial Numbers: 10022, 2001 thru 20002 and 20006.  Part #567912911 - Serial Numbers: 10001 thru 10003, 20000 and 40000.  Part #567912912 - Serial Numbers: 20003 thru 20004, 20006 thru 20008 and 40000 thru 40006.  Part #567912913 - Serial Numbers: 10012, 20002 and 20004 thru 20005.  Triple Arm: Part #567910917 - Serial Numbers: 20000 thru 20001, 20008 and 20010 thru 20019.  Part #567910918 - Serial Numbers: 12664 and 20039 thru 20040.  Part #567910965 - Serial Numbers: 12102 thru 12103, 12105 thru 12109, 20006 thru 20007 and 20010 thru 20016.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Austria, Australia, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Croatia, Hungary, Indonesia, Ireland, Iraq, Jordan, Japan, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Greenland, Greece, Hong Kong, United Arab Emirate, United Kingdom, Kenya, Kuwait, Sri Lanka, Luxembourg, Libya, Mongolia, Martinique, Mexico, Malaysia, Namibia, Nigeria, Netherlands, Norway, Oman, Panama, Peru, Philippines, Pakistan, Poland, Saint Pierre and Miquelon, Portugal, Reunion, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Thailand, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Uruguay, Venezuela, Serbia, Yemen, Mayotte and South Africa.

The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

Part Number: 03.120.023, with lot numbers:  1825699 1825946 1959344 1959346 3052800 3066995 3066996 3066997 3092693 3092737 3139434 3139480 3139483 3139485 3159152 3167363 3172147 3207364 3218030 3218068 3223545 3224270 3224271 3224275 3224581 3224582 3224583 3233445 3288206 3422091 3447606 3469240 3502469 3535235 3556421 3556422 3584316 3642892 3740917 3740919 3740920 3740924 3775480 3775482 3811200 7510644 7510645 7510647 7510648 7542178 7555756 7629268 7699116 7699117 7742370 7742371 7742372 7778806 7778807 7821741 7878176 7995396 8016667 8028575 8068778 8070887 8070891 8195690 8210669 8217914 8408715

General and Plastic Surgery Devices

1

No

Worldwide Distribution-US (nationwide) and internationlly to Canada

Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.

Part number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to US Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Hong Kong, India, Italy, Japan, Republic of Korea, Malaysia, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

SERFAS 90 degree Energy Probe, Part Number 279-350-101; || SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the hemostasis of blood vessels.

Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.

General and Plastic Surgery Devices

Unclassified

No

CA, IN, MO, NJ, VA

Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. || The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

SN 00048

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide Distribution and to the countries of : France, Australia, Belgium, Brazil, Switzerland, Chile, China, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Japan, Kuwait, Kazakhstan, Mexico, Netherlands, Norway, Russia, Sweden, Turkey, Taiwan and South Africa.

Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK0321 SK0131 SK0117 SK0149 SK0068 SK0197 SK0329 SK0185 SK0183 SK0253 SK0142 SK0141 SK0078 SK0128 SK0224 SK0192 SK0381 SK0085 SK0086 SK0247 SK0109 SK0088 SK0199 SK0200 SK0201 SK0215 SK0223 SK0336 SK0164 SK0256 SK0202 SK0214 SK0089 SK0165 SK0374 SK0374 SK0124 SK0260 SK0323 SK0252 SK0319 SK0327 SK0373 SK0335 SK0129 SK0184 SK0229 SK0110 SK0111 SK0350 SK0351 SK0136 SK0132 SK0190 SK0290 SK0158 SK0207 SK0341 SK0246 SK0226 SK0187 SK0232 SK0303 SK0328 SK0330 SK0315 SK0334 SK0204 SK0248 SK0344 SK0322 SK0219 SK0353 SK0222 SK0154 SK0318 SK0217 SK0196 SK0221 SK0172 SK0218 SK0220 SK0379 SK0213 SK0108 SK0177 SK0179 SK0101 SK0170 SK0233 SK0309 SK0234 SK0235 SK0105 SK0104 SD0002 SK0240 SK0360 SK0203 SK0091 SK0106 SK0206 SK0326 SK0294 SK0291 SK0237 SK0293 SK0238 SK0292 SK0272 SK0273 SK0356 SK0148 SK0095 SK0347 SK0135 SD0001 SK0259 SK0167 SK0371 SK0152 SK0087 SK0159 SK0225 SK0069 SK0099 SK0257 SK0178 SK0061 SK0343 SK0064 SK0163 SK0065 SK0180 SK0346 SK0285 SK0348 SK0280 SK0383 SK0239 SK0209 SK0258 SK0352 SK0331 SK0308 SK0271 SK0264 SK0358 SK0216 SK0039 SK0263 SK0162 SK0270 SK0059 SK0120 SK0143 SK0144 SK0279 SK0338 SK0265 SK0267 SK0051 SK0266 SK0316 SK0339 SK0145 SK0139 SK0074 SK0255 SK0314 SK0147 SK0186 SK0082 SK0295 SK0174 SK0055 SK0119 SK0058 SK0134 SK0242 SK0333 SK0250 SK0342 SK0302 SK0084 SK0092 SK0166 SK0090 SK0269 SK0114 SK0113 SK0375 SK0268 SK0296 SK0299 SK0168 SK0324 SK0300 SK0245 SK0083 SK0231 SK0287 SK0098 SK0298 SK0198 SK0275 SK0067 SK0066 SK0096 SK0254 SK0103 SK0230 SK0208 SK0070 SK0093 SK0332 SK0205 SK0044 SK0301 SK0094 SK0278 SK0286 SK0075 SK0317 SK0137 SK0349 SK0284 SK0122 SK0138 SK0146 SK0249 SK0320 SK0057 SK0228 SK0210 SK0079 SK0176 SK0155 SK0150 SK0156 SK0097 SK0307 SK0157 SK0288 SK0304 SK0244 SK0054 SK0123 SK0188 SK0189 SK0072 SK0175 SK0193 SK0062 SK0100 SK0382 SK0376 SK0173 SK0297 SK0261 SK0181 SK0063 SK0130 SK0359 SK0274 SK0112 SK0140 SK0262 SK0036 SK0236 SK0050 SK0378 SK0169 SK0081 SK0076 SK0345 SK0077 SK0380 SK0310 SK0211 SK0277 SK0276 SK0071 SK0227 SK0153 SK0048 SK0191 SK0289 SK0046 SK0127 SK0340 SK0160 SK0047 SK0049 SK0161 SK0171 SK0311 SK0073 SK0151 SK0325 SK0243 SK0115 SK0116 SK0212.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.