Lot Codes: 092514Z, 120814A, 011415H and 022415F

Ear, Nose, and Throat Devices

2

No

US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.

Spine Wave Access Kit, Catalog Number 10-1530 || Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. || Product Usage: || The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Code:9001482 Lots: 140915232 exp. 11/30/15 141216408 exp. 12/31/15 150116993 exp. 2/28/16 150217269 exp. 2/28/16 150518643 exp. 5/31/16 150317602 exp. 5/31/16

Ear, Nose, and Throat Devices

1

No

Distributed Only in Puerto Rico.

E.N.T. PK 7/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002234 Lots: 141015704 exp. 12/31/15 141216300 exp. 12/31/15 140915246 exp. 12/31/15 150217385 exp. 2/28/16 150317727 exp. 4/30/16 150418353 exp. 4/30/16 150418353 exp. 4/30/16 150518688 exp. 5/31/16 150619252 exp. 6/30/16

Ear, Nose, and Throat Devices

1

No

Distributed Only in Puerto Rico.

EAR PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002423 Lots: 141015705 exp. 12/31/15 141216302 exp. 2/28/16 150518811 exp. 5/31/16

Ear, Nose, and Throat Devices

1

No

Distributed Only in Puerto Rico.

EAR PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002498 Lots: 150116588 exp. 1/31/16 150116586 exp. 1/31/16 150116587 exp. 1/31/16

Ear, Nose, and Throat Devices

1

No

Distributed Only in Puerto Rico.

EENT PACK I (1) 10/CS CUSTOMED || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

LOTS: SL15201-01 (150719645) 31-JUL-16 SL15222 (150719959) 30-JUN-16 SL15223 (150719959) 30-JUN-16

Ear, Nose, and Throat Devices

1

No

Distributed only in Puerto Rico.

Catalog Number: 9001482 || ENT SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705

Ear, Nose, and Throat Devices

2

No

US Distribution in the states of KY and TX.

ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.

Ear, Nose, and Throat Devices

2

No

US Distribution in the states of KY and TX.

ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.

Covidien Cytosponge Cell Collection Kit. || Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. || Item code CYTO-KIT-R || Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.

Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.

Covidien Cytosponge Cell Collection Device. || Item code CYTO-101-01. || Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.

All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand

NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.

EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution

Pentax Video Bronchoscope || Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

EB-1970UK

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution

Ultrasound Video Bronchoscope || The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Model #'s 9106 and 9108

Ear, Nose, and Throat Devices

1

No

Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.

Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

Lot #202085 Stryker Product Number: 6001-420-000

Ear, Nose, and Throat Devices

2

No

US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.

Stryker PROFESS Registration Kit. || The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.

Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Bronchoscope

Model #'s:ECY-1570 and ECY-1570K

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Cytoscopes

Model #: VNL-1570STK

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Naso pharyngo Laryngoscopes

Lot numbers 17022809, 17030108,17022207,17022106, 17020805, 17020904, 17021798,17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661,16121260, 16121259, and 16112958

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Lot numbers 17030722, 17022421,17022020, 17020619, 17011918, 17012417, I 17010602, 16122724,16122239, 16122038, 16120563, and 16112362

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Lot numbers 17030728, 17022027, 17021426, 17013125, 17012724, 17011303, 16122767, 16122066, 16112965, and 16112164

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Lot numbers 17022451,17011750, 16120349, 16082989, 16081888, 16071987, 16062713, and 16060712

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it