Medtronic

a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962  Lot Number ID17J009 c) REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035

Orthopedic Devices

3

Yes

US Nationwide Distribution

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: || a) REF 6975205, 5mm || b) REF 6975206, 6mm || c) REF 6975207, 7mm || Product Usage: || The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

GTIN/UPN: 643169329218 Lot Number: H5399679

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm || Product Appliance, fixation, spinal intervertebral body

ALL SERIAL NUMBERS  UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement  1403: 00888707000116, 00888707000475  1407: '00888707000291, '00888707000727, '00888707000710,   00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472  1420: '00888707000420, '00888707000437, '00888707002660  (b) 1435: '00888707000109  1440: '00888707000260, '00888707001885, '00888707001496,  '00888707002745  (c) 1425: '00888707000093  1430: '00888707000307, '00888707000826, '00888707000833,  '00888707000840, '00888707000857, '00888707000871, '00888707000864,  '00888707000888, '00888707000901, '00888707000505, '00888707000895,  '00888707000918, '00888707001489, '00888707001779, '00888707001786,  '00888707001793, '00888707001809, '00888707001816, '00888707001823,  '00888707001830, '00888707001847, '00888707001854, '00888707001861,  '00888707001878, '00888707002738, '00888707002769, '00888707002776,  '00888707002783, '00888707002790, '00888707002806, '00888707004817  (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653,  '00888707000376

Cardiovascular Devices

3

Yes

Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, and Vietnam.

Heartware Medtronic HVAD System for cardiac use. Including the following parts: || (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 || (b) DC Adapter, Product numbers: 1435, 1440 || (c) AC Adapter, Product numbers: 1425, 1430 || (d) Battery Pack, Product number: 1650DE || Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.

Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013EP, MDB01014EP, MDB01015EP, MDB01016EP, MDB01017EP, MDB01018EP, MDB01019EP, MDB01036EP, MDB01037EP, MDB01038EP, MDB01039EP, MDB01040EP, MDB01041EP, MDB01042EP, MDB01043EP, MDB01044EP, MDB01045EP, MDB01046EP, MDB01047EP, MDB01048EP, MDB01049EP,  MDB01050EP, MDB01051EP, MDB01052EP, MDB01053EP, MDB01054EP, MDB01055EP, MDB01056EP, MDB01057EP, MDB01058EP, MDB01060EP, MDB01061EP, MDB01062EP, MDB01063EP, MDB01064EP, MDB01065EP, MDB01066EP, MDB01067EP, MDB01068EP, MDB01069EP, MDB01070EP, MDB01071EP, MDB01072EP, MDB01073EP, MDB01074EP, MDB01075EP, MDB01076EP, MDB01077EP, MDB01078EP, MDB01079EP, MDB01080EP, MDB01081EP, MDB01082EP, MDB01083EP, MDB01084EP, MDB01085EP, MDB01086EP, MDB01087EP, MDB01088EP, MDB01089EP, MDB01090EP, MDB01091EP, MDB01092EP, MDB01093EP, MDB01094EP, MDB01095EP, MDB01096EP, MDB01097EP, MDB01098EP, MDB01099EP, MDB01100EP, MDB01101EP, MDB01102EP, MDB01103EP, MDB01104EP, MDB01105EP, MDB01106EP, MDB01107EP, MDB01108EP, MDB01109EP, MDB01110EP, MDB01111EP, MDB01112EP, MDB01113EP, MDB01114EP, MDB01115EP, MDB01116EP, MDB01117EP, MDB01118EP, MDB01119EP, MDB01120EP, MDB01121EP, MDB01122EP, MDB01123EP, MDB01124EP, MDB01125EP, MDB01126EP, MDB01127EP, MDB01128EP, MDB01129EP, MDB01130EP, MDB01131EP, MDB01132EP, MDB01133EP, MDB01134EP, MDB01135EP, MDB01177EP, MDB01178EP, MDB01179EP, MDB01180EP, MDB01181EP, MDB01182EP, MDB01183EP, MDB01184EP, MDB01185EP, MDB01186EP, MDB01187EP, MDB01188EP, MDB01189EP, MDB01190EP, MDB01191EP, MDB01192EP, MDB01193EP, MDB01194EP, MDB01195EP, MDB01196EP, MDB01197EP, MDB01198EP, MDB01199EP, MDB01200EP, MDB01201EP, MDB01202EP, MDB01203EP, MDB01204EP, MDB01205EP, MDB01206EP, MDB01207EP, MDB01208EP, MDB01209EP, MDB01210EP, MDB01211EP, MDB01212EP, MDB01213EP, MDB01214EP, MDB01215EP, MDB01216EP, MDB01217EP, MDB01218EP, MDB01219EP, MDB01220EP, MDB01221EP, MDB01222EP, MDB01223EP, MDB01224EP, MDB01225EP, MDB01226EP, MDB01227EP, MDB01228EP, MDB01229EP, MDB01230EP, MDB01231EP, MDB01232EP, MDB01233EP, MDB01234EP, MDB01235EP, MDB01236EP, MDB01237EP, MDB01238EP, MDB01239EP, MDB01240EP, MDB01241EP, MDB01242EP, MDB01243EP, MDB01244EP, MDB01245EP, MDB01246EP, MDB01247EP, MDB01248EP, MDB01249EP, MDB01250EP, MDB01251EP, MDB01252EP, MDB01253EP, MDB01254EP, MDB01255EP, MDB01256EP, MDB01257EP, MDB01258EP, MDB01259EP, MDB01260EP, MDB01261EP, MDB01262EP, MDB01263EP, MDB01264EP, MDB01265EP, MDB01266EP, MDB01267EP, MDB01268EP, MDB01269EP, MDB01270EP, MDB01271EP, MDB01272EP, MDB01273EP, MDB01274EP, MDB01275EP, MDB01276EP, MDB01381EP, MDB01382EP, MDB01383EP, MDB01384EP, MDB01385EP, MDB01386EP, MDB01387EP, MDB01388EP, MDB01389EP, MDB01390EP, MDB01391EP, MDB01392EP, MDB01393EP, MDB01394EP, MDB01395EP, MDB01396EP, MDB02001EP, MDB02002EP, MDB02003EP, MDB02004EP, MDB02005EP, MDB02006EP, MDB02007EP, MDB02008EP, MDB02009EP, MDB02010EP, MDB02011EP, MDB02012EP, MDB02013EP, MDB02014EP, MDB02015EP, MDB02016EP, MDB02017EP, MDB02018EP, MDB02019EP, MDB02021EP, MDB02022EP, MDB02023EP, MDB02024EP, MDB02025EP, MDB02026EP, MDB02027EP, MDB02031EP, MDB02032EP, MDB02033EP, MDB02034EP, MDB02035EP, MDB02036EP, MDB02038EP, MDB02039EP, MDB02041EP, MDB02043EP, MDB02044EP, MDB02045EP, MDB02046EP, MDB02049EP, MDB02050EP, MDB02051EP, MDB02054EP, MDB02055EP, MDB02056EP, MDB02057EP, MDB02060EP, MDB02061EP, MDB02062EP, MDB02063EP, MDB02064EP, MDB02065EP, MDB02066EP, MDB02067EP, MDB02068EP, MDB02069EP, MDB02070EP, MDB02071EP, MDB02072EP, MDB02074EP, MDB02075EP, MDB02076EP, MDB02077EP, MDB02078EP, MDB02079EP, MDB02080EP, MDB02081EP, MDB02082EP, MDB02083EP, MDB02084EP, MDB02085EP, MDB02086EP, MDB02087EP, MDB02088EP, MDB02089EP, MDB02090EP, MDB02091EP, MDB02093EP, MDB02094EP, MDB02095EP, MDB02096EP, MDB02097EP, MDB02098EP, MDB02099EP, MDB02100EP, MDB02101EP, MDB02102EP, MDB02103EP, MDB02104EP, MDB02105EP, MDB02106EP, MDB02107EP, MDB02108EP, MDB02109EP, MDB02110EP, MDB02111EP, MDB02185EP, MDB02186EP, MDB02188EP, MDB02189EP, MDB02190EP, MDB02191EP, MDB02192EP, MDB02193EP, MDB02194EP, MDB02195EP, MDB02196EP, MDB02197EP, MDB02198EP, MDB02199EP, MDB02200EP, MDB02201EP, MDB02202EP, MDB02203EP, MDB02204EP, MDB02205EP, MDB02206EP, MDB02207EP, MDB02209EP, MDB02210EP, MDB02211EP, MDB02212EP, MDB02213EP, MDB02214EP, MDB02215EP, MDB02216EP, MDB02217EP, MDB02218EP, MDB02219EP, MDB02220EP, MDB02221EP, MDB02222EP, MDB02223EP, MDB02224EP, MDB02225EP, MDB02226EP, MDB02227EP, MDB02228EP, MDB02229EP, MDB02230EP, MDB02231EP, MDB02232EP, MDB02233EP, MDB02234EP, MDB02235EP, MDB02236EP, MDB02237EP, MDB02238EP, MDB02239EP, MDB02240EP, MDB02241EP, MDB02242EP, MDB02243EP, MDB02244EP, MDB02315EP, MDB02316EP, MDB02317EP, MDB02318EP, MDB02319EP, MDB02320EP, MDB02321EP, MDB02322EP, MDB02323EP, MDB02324EP, MDB02325EP, MDB02326EP, MDB02327EP, MDB02329EP, MDB02330EP, MDB02331EP, MDB02332EP, MDB02333EP, MDB02334EP, MDB02335EP, MDB02336EP, MDB02338EP, MDB02339EP, MDB02340EP, MDB02341EP, MDB02342EP, MDB02343EP, MDB02344EP, MDB02346EP, MDB02347EP, MDB02349EP, MDB02350EP, MDB02351EP, MDB02352EP, MDB02600EP, MDB02601EP, MDB02602EP, MDB02603EP, MDB02605EP, MDB02606EP, MDB02607EP, MDB02608EP, MDB02609EP, MDB02610EP, MDB02611EP, MDB02612EP, MDB02613EP, MDB02614EP, MDB02615EP, MDB02616EP, MDB02617EP, MDB02618EP, MDB02619EP, MDB02620EP, MDB02622EP, MDB02623EP, MDB02624EP, MDB02625EP, MDB02626EP, MDB02627EP, MDB02628EP, MDB02632EP, MDB02633EP, MDB02634EP, MDB02635EP, MDB02636EP, MDB02637EP, MDB02638EP, MDB02640EP, MDB02641EP, MDB02642EP, MDB02643EP, MDB02644EP, MDB02645EP, MDB02646EP, MDB02647EP, MDB02649EP, MDB02650EP, MDB02651EP, MDB02652EP, MDB02653EP, MDB02654EP, MDB02655EP, MDB02656EP, MDB02657EP, MDB02659EP, MDB02661EP, MDB02662EP, MDB02663EP, MDB02664EP, MDB02665EP, MDB02670EP, MDB02671EP, MDB02672EP, MDB02673EP, MDB02674EP, MDB02675EP, MDB02676EP, MDB02677EP, MDB02678EP, MDB02679EP, MDB02680EP, MDB02681EP, MDB02683EP, MDB02684EP, MDB02685EP, MDB02686EP, MDB02687EP, MDB02688EP, MDB02689EP, MDB02700EP, MDB02701EP, MDB02702EP, MDB02703EP, MDB02704EP, MDB02705EP, MDB02706EP, MDB02707EP, MDB02708EP, MDB02709EP, MDB02710EP, MDB02711EP, MDB02712EP, MDB02714EP, MDB02715EP, MDB02716EP, MDB02717EP, MDB02718EP, MDB02719EP, MDB02763EP, MDB02764EP, MDB02765EP, MDB02766EP, MDB02767EP, MDB02768EP, MDB02769EP, MDB02817EP, MDB02818EP, MDB02819EP, MDB02820EP, MDB02821EP, MDB02822EP, MDB02823EP, MDB02824EP, MDB02825EP, MDB02826EP, MDB02827EP, MDB02828EP, MDB02829EP, MDB02831EP, MDB02832EP, MDB02833EP, MDB02834EP, MDB02835EP, MDB02836EP, MDB02837EP, MDB02838EP, MDB02839EP, MDB02840EP, MDB02842EP, MDB02843EP, MDB02845EP, MDB02846EP, MDB02847EP, MDB02848EP, MDB02849EP, MDB02851EP, MDB02852EP, MDB02853EP, MDB02854EP, MDB02855EP, MDB02856EP, MDB02857EP, MDB02858EP, MDB02859EP, MDB02860EP, MDB02861EP, MDB02862EP, MDB02863EP, MDB02864EP, MDB02865EP, MDB02866EP, MDB02867EP, MDB02868EP, MDB02869EP, MDB02870EP, MDB02871EP, MDB02872EP, MDB02873EP, MDB02874EP, MDB02875EP, MDB02876EP, MDB02877EP, MDB02879EP, MDB02880EP, MDB02881EP, MDB02882EP, MDB02883EP, MDB02884EP, MDB02885EP, MDB02886EP, MDB02897EP, MDB02898EP, MDB02899EP, MDB02900EP, MDB02902EP, MDB02903EP, MDB02904EP, MDB02905EP, MDB02906EP, MDB02989EP, MDB02990EP, MDB02991EP, MDB02993EP, MDB02994EP, MDB02995EP, MDB02996EP, MDB02997EP, MDB02998EP, MDB02999EP, MDB03000EP, MDB03001EP, MDB03002EP, MDB03003EP, MDB03004EP, MDB03005EP, MDB03007EP, MDB03008EP, MDB03009EP, MDB03010EP, MDB03011EP, MDB03012EP, MDB03013EP, MDB03014EP, MDB03015EP, MDB03017EP, MDB03018EP, MDB03019EP, MDB03020EP, MDB03021EP, MDB03022EP, MDB03023EP, MDB03024EP, MDB03025EP, MDB03026EP, MDB03027EP, MDB03028EP, MDB03029EP, MDB03031EP, MDB03032EP, MDB03033EP, MDB03034EP, MDB03036EP, MDB03037EP, MDB03038EP, MDB03040EP, MDB03041EP, MDB03042EP, MDB03043EP, MDB03044EP, MDB03045EP, MDB03046EP, MDB03047EP, MDB03048EP, MDB03049EP, MDB03050EP, MDB03051EP, MDB03052EP, MDB03053EP, MDB03054EP, MDB03055EP, MDB03056EP, MDB03057EP, MDB03058EP, MDB03059EP, MDB03060EP, MDB03061EP, MDB03063EP, MDB03141EP, MDB03142EP, MDB03143EP, MDB03144EP, MDB03145EP, MDB03146EP, MDB03149EP, MDB03150EP, MDB03151EP, MDB03152EP, MDB03153EP, MDB03154EP, MDB03155EP,  MDB03156EP, MDB03157EP, MDB03158EP, MDB03159EP, MDB03161EP, MDB03163EP, MDB03164EP, MDB03165EP, MDB03167EP, MDB03168EP, MDB03169EP, MDB03171EP, MDB03172EP, MDB03173EP, MDB03174EP, MDB03175EP, MDB03176EP, MDB03177EP, MDB03178EP, MDB03179EP, MDB03180EP, MDB03181EP, MDB03182EP, MDB03183EP, MDB03184EP, MDB03185EP, MDB03186EP, MDB03187EP, MDB03188EP, MDB03189EP, MDB03190EP, MDB03191EP, MDB03192EP, MDB03193EP, MDB03194EP, MDB03195EP, MDB03196EP, MDB03197EP, MDB03198EP, MDB03199EP, MDB03200EP, MDB03201EP, MDB03202EP,MDB03203EP, MDB03204EP, MDB03206EP, MDB03207EP, MDB03208EP, MDB03209EP, MDB03210EP, MDB03211EP, MDB03214EP, MDB03215EP, MDB03216EP, MDB03217EP, MDB03219EP, MDB03220EP, MDB03221EP, MDB03222EP, MDB03223EP, MDB03224EP, MDB03225EP, MDB03226EP, MDB03227EP, MDB03228EP, MDB03230EP, MDB03231EP, MDB03232EP, MDB03233EP, MDB03235EP, MDB03236EP, MDB03237EP, MDB03238EP, MDB03418EP, MDB03419EP, MDB03420EP, MDB03422EP, MDB03424EP, MDB03425EP, MDB03426EP, MDB03428EP, MDB03429EP, MDB03430EP, MDB03431EP, MDB03432EP, MDB03433EP, MDB03434EP, MDB03435EP, MDB03437EP, MDB03438EP, MDB03439EP, MDB03441EP, MDB03442EP, MDB03443EP, MDB03444EP, MDB03445EP, MDB03446EP, MDB03447EP, MDB03448EP, MDB03449EP, MDB03450EP, MDB03453EP, MDB03454EP, MDB03507EP, MDB03508EP, MDB03509EP, MDB03510EP, MDB03511EP, MDB03512EP, MDB03513EP, MDB03514EP, MDB03515EP, MDB03516EP, MDB03517EP, MDB03518EP, MDB03520EP, MDB03521EP, MDB03522EP, MDB03523EP, MDB03524EP, MDB03525EP, MDB03527EP, MDB03528EP, MDB03529EP, MDB03530EP, MDB03531EP, MDB03532EP, MDB03533EP, MDB03534EP, MDB03535EP, MDB03536EP, MDB03537EP, MDB03538EP, MDB03539EP, MDB03540EP, MDB03541EP, MDB03542EP, MDB03543EP, MDB03544EP, MDB03545EP, MDB03546EP, MDB03548EP, MDB03549EP, MDB03550EP, MDB03551EP, MDB03552EP, MDB03553EP, MDB03554EP, MDB03555EP, MDB03556EP, MDB03558EP, MDB03559EP, MDB03560EP, MDB03561EP, MDB03562EP, MDB03563EP, MDB03564EP, MDB03565EP, MDB03566EP, MDB03567EP, MDB03568EP, MDB03569EP, MDB03570EP, MDB03571EP, MDB03572EP, MDB03573EP, MDB03574EP, MDB03575EP, MDB03576EP, MDB03577EP, MDB03578EP, MDB03579EP, MDB03580EP, MDB03581EP, MDB03582EP, MDB03583EP, MDB03585EP, MDB03586EP, MDB03587EP, MDB03588EP, MDB03589EP, MDB03590EP, MDB03592EP, MDB03594EP, MDB03595EP, MDB03596EP, MDB03597EP, MDB03598EP, MDB03599EP, MDB03600EP, MDB03601EP, MDB03602EP, MDB03603EP, MDB03604EP, MDB03605EP, MDB03606EP, MDB03677EP, MDB03678EP, MDB03679EP, MDB03680EP, MDB03682EP, MDB03683EP, MDB03684EP, MDB03685EP, MDB03686EP, MDB03687EP, MDB03688EP, MDB03689EP, MDB03690EP, MDB03691EP, MDB03765EP, MDB03767EP, MDB03768EP, MDB03769EP, MDB03770EP, MDB03771EP, MDB03772EP, MDB03773EP, MDB03774EP, MDB03775EP, MDB03777EP, MDB03778EP, MDB03779EP, MDB03780EP, MDB03781EP, MDB03782EP, MDB03784EP, MDB03785EP, MDB03786EP, MDB03787EP, MDB03788EP, MDB03789EP, MDB03790EP, MDB03791EP, MDB03792EP, MDB03793EP, MDB03794EP, MDB03796EP, MDB03797EP, MDB03798EP, MDB03799EP, MDB03801EP, MDB03802EP, MDB03803EP, MDB03804EP, MDB03805EP, MDB03806EP, MDB03807EP, MDB03808EP, MDB03809EP, MDB03811EP, MDB03812EP, MDB03814EP, MDB03816EP, MDB03818EP, MDB03820EP, MDB03821EP, MDB03822EP, MDB03832EP, MDB03833EP, MDB03834EP, MDB03835EP, MDB03836EP, MDB03837EP, MDB03839EP, MDB03840EP, MDB03841EP, MDB03842EP, MDB03843EP, MDB03844EP, MDB03845EP, MDB03846EP, MDB03847EP, MDB04041EP, MDB04042EP, MDB04043EP, MDB04044EP, MDB04045EP, MDB04046EP, MDB04047EP, MDB04048EP, MDB04049EP, MDB04050EP, MDB04051EP, MDB04052EP, MDB04053EP, MDB04054EP, MDB04055EP, MDB04057EP, MDB04059EP, MDB04061EP, MDB04062EP, MDB04063EP, MDB04064EP, MDB04065EP, MDB04066EP, MDB04067EP, MDB04068EP, MDB04069EP, MDB04070EP, MDB04071EP, MDB04073EP, MDB04074EP, MDB04075EP, MDB04076EP, MDB04077EP, MDB04078EP, MDB04079EP, MDB04080EP, MDB04081EP, MDB04082EP, MDB04083EP, MDB04084EP, MDB04085EP, MDB04087EP, MDB04088EP, MDB04090EP, MDB04093EP, MDB04095EP, MDB04096EP, MDB04097EP, MDB04098EP, MDB04099EP, MDB04100EP, MDB01020GP, MDB01021GP, MDB01022GP, MDB01023GP, MDB01024GP, MDB01137GP, MDB01138GP, MDB01139GP, MDB01140GP, MDB01141GP, MDB01142GP, MDB01143GP, MDB01144GP, MDB01145GP, MDB01146GP, MDB01147GP, MDB01148GP, MDB01149GP, MDB01150GP, MDB01151GP, MDB01152GP, MDB01153GP, MDB01154GP, MDB01155GP, MDB01156GP, MDB02549GP, MDB02550GP, MDB02551GP, MDB02553GP, MDB02555GP, MDB02556GP, MDB02558GP, MDB02559GP, MDB02560GP, MDB02561GP, MDB02562GP, MDB02563GP, MDB02565GP, MDB02566GP, MDB02567GP, MDB02568GP, MDB02569GP, MDB02570GP, MDB02571GP, MDB02572GP, MDB02573GP, MDB02574GP, MDB02947GP, MDB02949GP, MDB02950GP, MDB02951GP, MDB02952GP, MDB02955GP, MDB02956GP, MDB02957GP, MDB02960GP, MDB02961GP, MDB03295GP, MDB03296GP, MDB03297GP, MDB03298GP, MDB03299GP, MDB03300GP, MDB03301GP, MDB01030IP, MDB01031IP, MDB01032IP, MDB01033IP, MDB01034IP, MDB01157IP, MDB01158IP, MDB01159IP, MDB01160IP, MDB01161IP, MDB01162IP, MDB01163IP, MDB01164IP, MDB01165IP, MDB01166IP, MDB01167IP, MDB01168IP, MDB01169IP, MDB01170IP, MDB01171IP, MDB01172IP, MDB01173IP, MDB01174IP, MDB01175IP, MDB01176IP, MDB02575IP, MDB02576IP, MDB02577IP, MDB02578IP, MDB02580IP, MDB02581IP, MDB02582IP, MDB02583IP, MDB02584IP,MDB02585IP, MDB02586IP, MDB02587IP, MDB02588IP, MDB02589IP, MDB02590IP, MDB02591IP, MDB02592IP, MDB02593IP, MDB02594IP, MDB02595IP, MDB02596IP, MDB02597IP, MDB02598IP, MDB02962IP, MDB02963IP, MDB02964IP, MDB02965IP, MDB02966IP, MDB02967IP, MDB02968IP, MDB02969IP, MDB02970IP, MDB02971IP, MDB02972IP, MDB01827FP, MDB01828FP, MDB01829FP, MDB01830FP, MDB01831FP, MDB01852FP, MDB01853FP, MDB01854FP, MDB01855FP, MDB01856FP, MDB02250FP, MDB02251FP, MDB02252FP, MDB02253FP, MDB02254FP, MDB02255FP, MDB02256FP, MDB02257FP, MDB02363FP, MDB02364FP, MDB02365FP, MDB02366FP, MDB02367FP, MDB02368FP, MDB02369FP, MDB02782FP, MDB02784FP, MDB02785FP, MDB02786FP, MDB02787FP, MDB02788FP, MDB02789FP, MDB02790FP, MDB02791FP, MDB02974FP, MDB02975FP, MDB02976FP, MDB02977FP, MDB02978FP, MDB02979FP, MDB02980FP, MDB02981FP, MDB03359FP, MDB03361FP, MDB03362FP, MDB03364FP, MDB03365FP, MDB03366FP, MDB03367FP, MDB03368FP, MDB03370FP, MDB03371FP, MDB03372FP, MDB03373FP, MDB03375FP, MDB03383FP, MDB03384FP, MDB03385FP, MDB03386FP, MDB03388FP, MDB03389FP, MDB03390FP, MDB03391FP, MDB03392FP, MDB04003FP, MDB04004FP, MDB04006FP, MDB04007FP, MDB01822SP, MDB01823SP, MDB01824SP, MDB01825SP, MDB01826SP, MDB01864SP, MDB01865SP, MDB01866SP, MDB01867SP, MDB01868SP, MDB02160SP, MDB02161SP, MDB02162SP, MDB02163SP, MDB02164SP, MDB02245SP, MDB02246SP, MDB02247SP, MDB02248SP, MDB02249SP, MDB02353SP, MDB02354SP, MDB02355SP, MDB02356SP, MDB02357SP, MDB02358SP, MDB02359SP, MDB02360SP, MDB02361SP, MDB02362SP, MDB02770SP, MDB02771SP, MDB02772SP, MDB02773SP, MDB02774SP, MDB02775SP, MDB02776SP, MDB02777SP, MDB02778SP, MDB02779SP, MDB02780SP, MDB02781SP, MDB02982SP, MDB02983SP, MDB02984SP, MDB02985SP, MDB02986SP, MDB02987SP, MDB02988SP, MDB01277UP, MDB01279UP, MDB01282UP, MDB01284UP, MDB01287UP, MDB01289UP, MDB01302UP, MDB01419UP, MDB01438UP, MDB01448UP, MDB01482UP, MDB01486UP, MDB01488UP, MDB01857UP, MDB01858UP, MDB01859UP, MDB01860UP, MDB01861UP, MDB01862UP, MDB01863UP, MDB01931UP, MDB01932UP, MDB01933UP, MDB01934UP, MDB01936UP, MDB01940UP, MDB01949UP, MDB01950UP, MDB01956UP, MDB01961UP, MDB01962UP, MDB01963UP, MDB01964UP, MDB01965UP, MDB01966UP, MDB01967UP, MDB01968UP, MDB01969UP, MDB01970UP, MDB01972UP, MDB01974UP, MDB01975UP, MDB01976UP, MDB01978UP, MDB01979UP, MDB01980UP, MDB01981UP, MDB01982UP, MDB01984UP, MDB01985UP, MDB01988UP, MDB01989UP, MDB01990UP, MDB01991UP, MDB01992UP, MDB01993UP, MDB01994UP, MDB01995UP, MDB01996UP, MDB01997UP, MDB01998UP, MDB01999UP, MDB02143UP, MDB02165UP, MDB02166UP, MDB02167UP, MDB02168UP, MDB02169UP, MDB02170UP, MDB02171UP, MDB02172UP, MDB02173UP, MDB02174UP, MDB02175UP, MDB02176UP, MDB02177UP, MDB02178UP, MDB02179UP, MDB02180UP, MDB02181UP, MDB02182UP, MDB02183UP, MDB02184UP, MDB02259UP, MDB02260UP, MDB02261UP, MDB02262UP, MDB02264UP, MDB02267UP, MDB02268UP, MDB02269UP, MDB02271UP, MDB02273UP, MDB02274UP, MDB02275UP, MDB02276UP, MDB02277UP, MDB02278UP, MDB02280UP, MDB02281UP, MDB02282UP, MDB02284UP, MDB02285UP, MDB02286UP, MDB02289UP, MDB02292UP, MDB02293UP, MDB02295UP, MDB02296UP, MDB02298UP, MDB02301UP, MDB02303UP, MDB02304UP, MDB02305UP, MDB02307UP, MDB02308UP, MDB02309UP, MDB02310UP, MDB02311UP, MDB02312UP, MDB02720UP, MDB02721UP, MDB02722UP, MDB02723UP, MDB02725UP, MDB02726UP, MDB02727UP, MDB02728UP, MDB02729UP, MDB02730UP, MDB02731UP, MDB02734UP, MDB02735UP, MDB02736UP, MDB02737UP, MDB02738UP, MDB02739UP, MDB02740UP, MDB02741UP, MDB02742UP, MDB02744UP, MDB02745UP, MDB02746UP, MDB02747UP, MDB02748UP, MDB02749UP, MDB02750UP, MDB02751UP, MDB02752UP, MDB02753UP, MDB02754UP, MDB02755UP, MDB02756UP, MDB02757UP, MDB02758UP, MDB02759UP, MDB02760UP, MDB02761UP, MDB02762UP, MDB02924UP, MDB02925UP, MDB02926UP, MDB02927UP, MDB02928UP, MDB02929UP, MDB02930UP, MDB02931UP, MDB02932UP, MDB02934UP, MDB02935UP, MDB02936UP, MDB02937UP, MDB02938UP, MDB02939UP, MDB02940UP, MDB02942UP, MDB02943UP, MDB02944UP, MDB02945UP, MDB02946UP, MDB01278UP, MDB01280UP, MDB01281UP, MDB01283UP, MDB01285UP, MDB01286UP, MDB01288UP, MDB01290UP, MDB01291UP, MDB01292UP, MDB01293UP, MDB01294UP, MDB01295UP, MDB01296UP, MDB01297UP, MDB01298UP, MDB01299UP, MDB01300UP, MDB01301UP, MDB01303UP, MDB01304UP, MDB01305UP, MDB01306UP, MDB01485UP, MDB01489UP, MDB01935UP, MDB01937UP, MDB01938UP, MDB01939UP, MDB01941UP, MDB01942UP, MDB01943UP, MDB01944UP, MDB01945UP, MDB01946UP, MDB01947UP, MDB01951UP, MDB01952UP, MDB01954UP, MDB01955UP, MDB01957UP, MDB01959UP, MDB01971UP, MDB01977UP, MDB01986UP, MDB02112UP, MDB02113UP, MDB02114UP, MDB02115UP, MDB02116UP, MDB02117UP, MDB02118UP, MDB02119UP, MDB02121UP, MDB02122UP, MDB02123UP, MDB02124UP, MDB02125UP, MDB02126UP, MDB02127UP, MDB02128UP, MDB02129UP, MDB02130UP, MDB02131UP, MDB02132UP, MDB02133UP, MDB02134UP, MDB02135UP, MDB02136UP, MDB02137UP, MDB02138UP, MDB02139UP, MDB02140UP, MDB02141UP, MDB02142UP, MDB02145UP, MDB02146UP, MDB02147UP, MDB02148UP, MDB02149UP, MDB02150UP, MDB02151UP, MDB02152UP, MDB02153UP, MDB02154UP, MDB02155UP, MDB02157UP, MDB02158UP, MDB02159UP, MDB02258UP, MDB02792UP, MDB02793UP, MDB02794UP, MDB02795UP, MDB02797UP, MDB02798UP, MDB02799UP, MDB02800UP, MDB02801UP, MDB02802UP, MDB02803UP, MDB02804UP, MDB02805UP, MDB02806UP, MDB02807UP, MDB02809UP, MDB02811UP, MDB02812UP, MDB02813UP, MDB02814UP, MDB02815UP, MDB02816UP, MDB02887UP, MDB02888UP, MDB02889UP, MDB02890UP, MDB02891UP, MDB02892UP, MDB02893UP, MDB02894UP, MDB02895UP, MDB02896UP, MDB02907UP, MDB02908UP, MDB02909UP, MDB02910UP, MDB02911UP, MDB02912UP, MDB02913UP, MDB02914UP, MDB02915UP, MDB02916UP, MDB02917UP, MDB02918UP, MDB02919UP, MDB02920UP, MDB02922UP, MDB02923UP, MDB03627UP, MDB03628UP, MDB03629UP, MDB03630UP, MDB03631UP, MDB03632UP, MDB03633UP, MDB03634UP, MDB03635UP, MDB03636UP, MDB03637UP, MDB03638UP, MDB03639UP, MDB03640UP, MDB03641UP, MDB03642UP, MDB03643UP, MDB03644UP, MDB03645UP, MDB03646UP, MDB03647UP, MDB03648UP, MDB03649UP, MDB03650UP, MDB03651UP, MDB03652UP, MDB03653UP, MDB03654UP, MDB03655UP, MDB03656UP, MDB03657UP, MDB03659UP, MDB03660UP, MDB03661UP, MDB03662UP, MDB03663UP, MDB03664UP, MDB03666UP, MDB03667UP, MDB03668UP, MDB03669UP, MDB03670UP, MDB03671UP, MDB03672UP, MDB03673UP, MDB03674UP, MDB03675UP, MDB03676UP, MDB03692UP, MDB03693UP, MDB03694UP, MDB03695UP, MDB03696UP, MDB03698UP, MDB03699UP, MDB03700UP, MDB03701UP, MDB03702UP, MDB03703UP, MDB03704UP, MDB03705UP, MDB03706UP, MDB03707UP, MDB03708UP, MDB03709UP, MDB03710UP, MDB03711UP, MDB03712UP, MDB03713UP, MDB03714UP, MDB03716UP, MDB03717UP, MDB03718UP, MDB03719UP, MDB03720UP, MDB03722UP, MDB03724UP, MDB03725UP, MDB03726UP, MDB03727UP, MDB03728UP, MDB03729UP, MDB03730UP, MDB03731UP, MDB03732UP, MDB03733UP, MDB03734UP, MDB03735UP, MDB03737UP, MDB03738UP, MDB03739UP, MDB03740UP, MDB03743UP, MDB03744UP, MDB03745UP, MDB03746UP, MDB03747UP, MDB03748UP, MDB03749UP, MDB03750UP, MDB03751UP, MDB03848UP, MDB03849UP, MDB03850UP, MDB03851UP, MDB03852UP, MDB03853UP, MDB03854UP, MDB03855UP, MDB03856UP, MDB03857UP, MDB03858UP, MDB03859UP, MDB03861UP, MDB03862UP, MDB03863UP, MDB03864UP, MDB03865UP, MDB03866UP, MDB03867UP, MDB03868UP, MDB03869UP, MDB03870UP, MDB03871UP, MDB03872UP, MDB03873UP, MDB03874UP, MDB03875UP, MDB03876UP, MDB03878UP, MDB03879UP, MDB03881UP, MDB03882UP, MDB03883UP, MDB03884UP, MDB03885UP, MDB03886UP, MDB03888UP, MDB03889UP, MDB03890UP, MDB03891UP, MDB03892UP, MDB03893UP, MDB03894UP, MDB03895UP, MDB03897UP, MDB03898UP, MDB03899UP, MDB03902UP, MDB03903UP, MDB03904UP, MDB03905UP, MDB03906UP, MDB03907UP, MDB03908UP, MDB03909UP, MDB03910UP, MDB03911UP, MDB03912UP, MDB03914UP, MDB03916UP, MDB03917UP, MDB03918UP, MDB03919UP, MDB03920UP, MDB03921UP, MDB03922UP, MDB03923UP, MDB03924UP, MDB03925UP, MDB03927UP, MDB03928UP, MDB03930UP, MDB03931UP, MDB03932UP, MDB03933UP, MDB03935UP, MDB03936UP, MDB03937UP, MDB03938UP, MDB03939UP, MDB03940UP, MDB03941UP, MDB03942UP, MDB03945UP, MDB03946UP, MDB03947UP, MDB03948UP, MDB03949UP, MDB03950UP, MDB03951UP, MDB03952UP, MDB03953UP, MDB03954UP, MDB03955UP, MDB03956UP, MDB03957UP, MDB03958UP, MDB03959UP, MDB03960UP, MDB03961UP, MDB03962UP, MDB03964UP, MDB03965UP, MDB03966UP, MDB03967UP, MDB03969UP, MDB03970UP, MDB03971UP, MDB03972UP, MDB03973UP, MDB03974UP, MDB03976UP, MDB03977UP, MDB03978UP, MDB03979UP, MDB03980UP, MDB03982UP, MDB03983UP, MDB03984UP, MDB03985UP, MDB03987UP, MDB03988UP, MDB03989UP, MDB03990UP, MDB03991UP, MDB03992UP, MDB03993UP, MDB03994UP, MDB03995UP, MDB03996UP, MDB04009UP, MDB04010UP, MDB04011UP, MDB04012UP, MDB04013UP, MDB04014UP, MDB04015UP, MDB04017UP, MDB04018UP, MDB04019UP, MDB04020UP, MDB04021UP, MDB04022UP, MDB04023UP, MDB04024UP, MDB04025UP, MDB04026UP, MDB04027UP, MDB04028UP, MDB04029UP, MDB04030UP, MDB04031UP, MDB04032UP, MDB04033UP, MDB04034UP, MDB04035UP, MDB04037UP, MDB04038UP, MDB04039UP, MDB04040UP, MDB02629EP, MDB02630EP, MDB02631EP.

Cardiovascular Devices

3

No

Domestic distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Republic, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sierra Leone, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Turkey, United Arab Emirates, United Kingdom.

Single Chamber Temporary External Pacemaker, Model 53401

All serial numbers beginning with PIM4. The serial number have the form of PIM4xxxxxx.

The devices have been distributed nationwide in the United States and worldwide. 2,151 units have been distributed in the United States, and 387 units have been distributed worldwide outside the U.S.

GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)