I Ia The listed prociuct is classified as Class Ha as stateci in Arinex IX of EC Directive 93/42/EEC Chief Operating Officer Declaration ofconíormity / / ĺ: Jř Certificate issued by: BSI (UK) Certificate / Registration No.: CE 584746 Kitemark Court, Davy Avenue, Knowhill, Milton Keynes MK5 SPP (Notified under No. 0086 to the EC Commission) CERTIFICATION OF A FULL QUAUTY ASSURANCE SYSTM AnneX II - This deciaration is based on EC Directive 93/42/EEC AnneX II Article 3 of this Directive. 3 amended per MDD 2007/47/EC, which apply to them and covered by CE mark 0086 as stated in OsteoMed Management Representathe: declaration are available upon request. A list of product Lot numbers and/or serial numbers for the shipment therefore covered by this thís Declaration relates are in conformity and meet the provisions of EC Directive 93/42/EEC, as Date Of EXpiry: 08/06/2015 We, OsteoMed, ensure and declare under our sole responsibility that the listed products to which According to the EC Directive 93/42/EEC amencied per MDD 2007/47/EC Declaration of Conformity Bill Melendez, PE Date J I I Outside USA: 972/677-4600 Customer Service: 800/456-7779 3885 Arapaho Road Addison, TX 75001, USA Fishbourne, Chichester 25 Baker Close Tet: +44 (0) 1243 779 550 OsteoMed Shotwelt SL Carr Manufacturer: European Authorized Representative: West Sussex, UK P018 8BJ
Preklad z anglického jazyka VYHLÁSENIE O ZHODE Podľa smernice ES 93/42/EHS v znení smernice 2007/47/ES o zdravotníckych pomóckach Výrobca: OsteoMed Európsky splnomocnený zástupca Shotwell SL Carr 3885 Ara paho Road 25 Baker Close Addison, TX 75001, USA Fishbourne, Chichester Služby zákazníkom: 800/456-7779 West Sussex, UK P018 8BJ Mimo USA: 972/677-4600 Tel.: +44(0) 1243 779 550 My, spoločnosť OsteoMed, zaručujeme a vyhlasujeme na svoju výhradnú zodpovednosť, že uvedené výrobky, ktorých sa toto vyhlásenie týka, sú v súlade s ustanoveniami a spíňajú ustanovenia ES smernice 93/42/EHS v znení smernice 2007/47/ES pre zdravotnícke pomůcky, ktoré pre ne platia, a na ktoré sa vzťahuje značka CE 0086 ako je uvedené v prílohe II, článku 3 tejto smernice. Uvedené výrobky sú klasifikované v triede ha tak, ako je uvedené v prílohe IX ES smernice 93/42/EHS Toto vyhlásenie je založené na smernici 93/42/EHS, príloha II, článok 3 OSVEDČENIE O ZABEZPEČENÍ KOMPLEXNÉHO SYSTÉMU RIADENIA KVALITY Certifikát vystavený (kým): BSI (UK) Kitemark Court, Davy Avenue, Knowhill, Milton Keynes MK5 8PP (oznámené Komisii ES pod číslom 0086) Certifikát / Registračné číslo: ES 584746 Platný do: 06. 08. 2015 Čísla šarží a/alebo výrobné čísla výrobkov v zásielke, ktoré podliehajú tomuto vyhláseniu, sú k dispozícií na vyžiadanie. Zástupca vedenia spoločnosti OsteoMed: Podpis nečitateľný 18. 07. 2012 Bill Melendez, PE Dátum Prevádzkový riaditel Vyhlásenie o zhode ha
full transiation into the Slovak language and Ing. Ingrid \ĺ, O /- -. numher QJ3/ been duly entered into the journal urider the document in English. This translation has spravodi ivosti Českej republiky Spr jazyka menovaná dekrétom ministra language appointed by the Minister of cornpiies verbatim with the attached Decree dated May 12. 199 7 I conlrm hereby that this document is a correct and Justice of the Czech Republic by Spr 5 6/97 Ako súdna ti močníčka slovenského As a sworn translator of the Slovak slovenčiny a súhlasí doslovne so zapisany do dennika ako polozka c. presným a úplným prek[adom do znenĺm pripojenej listiny v angiickom potvrdzujem, že tento dokument je jazyku. Tlmočnícky úkon hol riadne 56/97 zo dňa 12. mája, 1997 týmto Sworn Translator s Certilkate Tlmočnícka doložka _ -_) j/l (P I -
DeclarationofConformityClassIIaPartsListing PartNo. PartDescription GMDN 2020300 2.0mmLockingScrewBendingInsert 2060300 2.4mmLockingScrewBendingInsert 2070120 24gaugeStainlessSteelWire P46644 2100006T 15mm,"L"Template 2100010T 18mm,Right"L"Template 2100014T 23mmRight"L",Template 2100038T 18HoleStraightPlate,Template 2140050T 33mm4HoleSemiCompressionTemplate 2140051T 33mm4HoleEDCTemplate 2140052T 48mm6HoleEDCTemplate 2140053T 38mm4HoleEDCTemplate 2140055T ShortAngledEDCTemplate 2140057T LongAngledEDCTemplate 2140060T RightReconstructionTemplate 2140064T StraightReconstructionTemplate 2140201T ReconstructionTemplate4x12Hole, 2140203T ReconstructionTemplate5x16Hole 2140205T ReconstructionTemplate,Full,5x20x5 2140206T ReconstructionTemplate,Full,5x20x5 2140207T ReconstructionTemplate,Straight,14Hole 2140208T ReconstructionTemplate,Straight,18Hole 2140210T FractureTemplate,4HoleDCP,32mm 2140211T FractureTemplate,4HoleDCP,34mm 2140212T FractureTemplate,4HoleDCP,37mm 2140213T FractureTemplate,6HoleDCP,47mm 2140214T FractureTemplate,6HoleDCP,49mm 2140215T FractureTemplate,6HoleDCP,52mm 2140216T FractureTemplate,8HoleDCP,59mm 2140219T 2x2HoleAngledFracturePlateTemplate 2140220T 3x3HoleAngledFracturePlateTemplate 2140221T RigidComminutedFracturePlateTemplate 2140231T MFx 2.0mmReductionTemplate,4Hole 2140251T MFx 2.4mmReductionTemplate,4Hole 2140262T MFx 125 ContouredReconstructionTemplate,4x12,Right&Left 2140264T MFx 125 ContouredReconstructionTemplate,5x16,Right&Left 2140265T MFx 125 ContouredReconstructionTemplate,5x20x5,Full 2140266T MFx 125 ContouredReconstructionTemplate,5x16x5,Full 2140400T 2.0mmLockingFracturePlate,4Hole,Short,Template 2140401T 2.0mmLockingFracturePlate,4Hole,Medium,Template Page1of12
PartNo. PartDescription GMDN 2140402T 2.0mmLockingFracturePlate,6Hole,Template 2140403T 2.0mmLockingPlate,Comminution,Template 2161201 0.9mmPilotDrill,LogicTMJr.OsteoPower 2161202 0.9mmPilotDrill,LogicTMJr.,JLatch 2200000 0.9mmPilotDrill,JLatch 2200001 1.0mmPilotDrill,JLatch 2200002 1.3mmPilotDrill,JLatch,12mm 2200003 1.6mmPilotDrill,JLatch 2200004 1.6mmPilotDrill,Long,JLatch 2200005 2.0mmPilotDrill,JLatch,12mm 2200006 2.0mmPilotDrill,Long,JLatch 2200007 1.6mmPilotDrill,Manual 2200008 2.0mmPilotDrill,Manual 2200011 1.0mmPilotDrill,4mmStop,JLatch 2200012 1.6mmPilotDrill,6mmStop,JLatch 2200013 1.6mmPilotDrill,4mmStop,JLatch 2200015 0.9mmPilotDrill,3mmStop,JLatch 2200062 1.3mmPilotDrill,JLatch,16mm 2200063 1.3mmPilotDrill,Manual 2200064 1.3mmPilotDrill,DentalLatch 2200065 1.0mmPilotDrill,8mmStop,DentalLatch 2200066 1.0mmPilotDrill,4mmStop,DentalLatch 2200089 1.0mmPilotDrill,6mmStop,JLatch 2200091 1.3mmPilotDrill,4mmStop,JLatch 2200092 1.3mmPilotDrill,4mmStop,Manual 2200098 1.3mmPilotDrill,Stryker100kCommand1 2200103 1.6mmPilotDrill,16mm,DentalLatch 2200104 1.6mmCalibratedDrillBit,DLatch 2200105 2.0mmPilotDrill,16mm,DentalLatch 2200106 2.0mmPilotDrill,16mm,DentalLatch 2200107 1.6mmPilotDrill,Calibrated,LongPointedCannula,JLatch 2200108 2.0mmPilotDrill,Calibrated,LongPointedCannula,JLatch 2200109 1.6mmPilotDrill,Calibrated,LongPointedCannula,OsteoPower 2200113 1.6mmPilotDrill,DentalLatch 2200115 2.0mmPilotDrill,10mm,DentalLatch 2200116 1.6mmPilotDrill,6mm,DentalLatch 2200117 1.6mmTwistDrill,4mmStop,Short,DentalLatch 2200118 1.6mmTwistDrill,6mmStop,Short,DentalLatch 2200165 1.0mmPilotDrill,12mmStop,DentalLatch 2200202 1.6mmPilotDrill,Calibrated,ShortPointedCannula,JLatch 2200204 1.6mmPilotDrill,LongCalibrated,JLatch 2200205 2.0mmPilotDrill,Calibrated,ShortPointedCannula,JLatch Page2of12
PartNo. PartDescription GMDN 2200206 2.0mmPilotDrill,LongCalibrated,JLatch 2200209 1.3mmPilotDrill,JLatch,ExtendedLength 2200251 MFx 1.6mmRainbowPilotDrill,ShortPointedCannula,JLatch 2200252 MFx 2.0mmRainbowPilotDrill,ShortPointedCannula,JLatch 2200253 MFx 1.6mmRainbowPilotDrill,LongPointedCannula,JLatch 2200254 MFx 2.0mmRainbowPilotDrill,LongPointedCannula,JLatch 2200255 MFx 1.6mmRainbowPilotDrill,BluntCannula,JLatch 2200256 MFx 2.0mmRainbowPilotDrill,BluntCannula,JLatch 2200300 0.9mmPilotDrill,OSTEOPOWERTM 2200301 1.0mmPilotDrill,OSTEOPOWERTM 2200302 1.3mmPilotDrill,12mmStop,OSTEOPOWER 2200303 1.6mmPilotDrill,OSTEOPOWER 2200304 1.6mmPilotDrill,Long,OSTEOPOWER 2200305 2.0mmPilotDrill,OSTEOPOWER 2200306 2.0mmPilotDrill,Long,OSTEOPOWER 2200307 1.6mmPilotDrill,Calibrated,Mandible,OSTEOPOWER 2200308 PilotDrill,OsteoPowerMaxi,LongCalibrated,2.0mm 2200309 1.3mmPilotDrill,ExtendedLength,OSTEOPOWER 2200310 1.6mmPilotDrill,Long,OSTEOPOWER 2200311 1.0mmPilotDrill,4mmStop,OSTEOPOWERTM 2200312 1.6mmPilotDrill,6mmStop,OSTEOPOWER 2200313 1.6mmPilotDrill,4mmStop,OSTEOPOWER 2200316 1.6mmPilotDrill,8mmStop,OsteoPower 2200318 0.9mmPilotDrill,3mmStop,JLatch 2200319 0.9mmPilotDrill,4mmStop,JLatch 2200320 0.9mmPilotDrill,5mmStop,JLatch 2200324 1.6mmPilotDrill6mmStopRobust 2200330 0.7mmPilotDrill,14mm,OsteoPower 2200331 1.1mmPilotDrill,18mm,OsteoPower 2200332 2.4mmPilotDrill,OsteoPower 2200333 3.0mmPilotDrill,OsteoPower 2200362 1.3mmPilotDrill,16mmStop,OsteoPower 2200560 2.0mmPilotDrill,Long,MandibleSystem 2200561 1.6mmPilotDrill,Long,MandibleSystem 2200563 2.0mmPilotDrill,Long,MandibleSystem,OSTEOPOWER 2200565 1.6mmPilotDrill,Mandible,OSTEOPOWER 2200621 1.6mmTwistDrill,16mmStop,JLatch 2200706 1.0mmPilotDrill,8mmStop 2200707 1.0mmPilotDrill,12mmStop 2200708 1.3mmPilotDrill,8mmStop 2200709 1.6mmPilotDrill,22mmStop 2220004 1.1mmPilotDrill,4mmStop,Jlatch Page3of12
PartNo. PartDescription GMDN 2220005 1.1mmPilotDrill,4mmStop,Manual 2220006 1.1mmPilotDrill,6mmStop,Jlatch 2220010 1.1mmPilotDrill,3MLatch,4mmStop 2220011 1.1mmPilotDrill,3MLatch,6mmStop 2220300 1.1mmPilotDrill,4mmStop 2220301 1.1mmPilotDrill,6mmStop 2220304 1.1mmPilotDrill,4mmStop,OsteoPower 2220306 1.1mmPilotDrill,6mmStop,OsteoPower 2300032 ContraAngleDisposableSet,7mmPlunge,3pc 2300034 ContraAngleDisposableSet,11mmPlunge,3pc 2500049 1.3mmPilotDrill,4mmStop,JLatch 2500050 1.3mmPilotDrill,6mmStop,JLatch 2500051 1.3mmPilotDrill,8mmStop,JLatch 2500052 1.3mmPilotDrill,8mmStop,OsteoPower 2500053 1.3mmPilotDrill,6mmStop,OsteoPower 2500054 1.3mmPilotDrill,4mmStop,OsteoPower 2500072 AutoTap,1.6mm,4mmStop,AutoDriver 2500073 AutoTap,1.6mm,6mmStop,AutoDriver 2500074 AutoTap,1.6mm,8mmStop,AutoDriver 2500075 AutoTap,2.0mm,4mmStop,AutoDriver 2500076 AutoTap,2.0mm,8mmStop,AutoDriver 2500077 AutoTap,2.0mm,8mmStop,AutoDriver 3141456T CalFix,CalcanealPlateTemplate,56mm 3141465T CalFix,CalcanealPlateTemplate,65mm 3141474T CalFix,CalcanealPlateTemplate,74mm 3160005 2.3mmCannulatedDrill,Manual 3160013 1.7mmCannulatedDrill,QuickRelease 3160014 1.7mmCannulatedDrill,Long,QuickRelease 3160015 2.3mmCannulatedDrill,QuickRelease 3160016 4.7mmCannulatedDrill 3160023.110x11.8"PartiallyThreadedSteinmannPin 3160105 1.7mmCannulatedDrill,Manual 3160107.035x4"GuideWire P46646 3160116 1.7mmCannulatedDrill,Long,Manual 3160124 2.4mmPilotDrill,Cannulated,QuickRelease 3160127 1.7mmDrill/CountersinkCombo,Short,Manual 3160128 1.7mmDrill/CountersinkCombo,Long,Manual 3160227 2.3mmDrill/Countersink,Short,Manual 3160228 2.4mmDrill/Countersink,Long,Manual 3160316 2.0/2.4mmProximalCortexDrill 3160317 2.9mmProximalCortexDrill,Manual 3160320 2.0/2.4mmProximalCortexDrill,QuickRelease Page4of12
PartNo. PartDescription GMDN 3160321 2.9mmProximalCortexDrill,QuickRelease 3160322 2.4mmProximalCortexDrill,Manual 3160323 2.4mmProximalCortexDrill,QuickRelease 3160327 2.7mmCannulatedDrill,Manual 3160427 2.7mmCannulatedDrill,QuickRelease 3160917 1.7mmCannulatedDrill,Fusion,Manual 3160920 2.0mmCannulatedDrill,Fusion,Manual 3161017 1.7mmCannulatedDrill,Fusion,QuickRelease 3161020 2.0mmCannulatedDrill,Fusion,QuickRelease 3200007 1.0mmPilotDrill,JLatch 3200010 1.3mmPilotDrill,JLatch 3200012 1.8mmPilotDrill,JLatch 3200013 2.0mmPilotDrill,JLatch 3200014 1.0mmPilotDrill,Manual 3200016 1.3mmPilotDrill,Manual 3200018 1.8mmPilotDrill,Manual 3200019 2.0mmPilotDrill,Manual 3200124 2.4mmPilotDrill,QuickRelease 3200135 3.5mmPilotDrill,QuickRelease 3200307 1.2mmScrewPilotDrillAssy 3200310 1.3mmPilotDrill,OsteoPower 3200312 1.8mmPilotDrill,OsteoPower 3200313 2.0mmPilotDrill,OsteoPower 3200407 4.0mmx228mmSteinmannPin,FullyThreaded 3200408 4.8mmx229mmSteinmannPin,Smooth 3200409 5.4mmx229mmSteinmannPin,PartiallyThreaded 3201001 1.2mm/1.6mmPlateHoldingTak 3201002 2.0mm/2.4mmPlateHoldingTak 3201011 1.2mm/1.6mmThreadedTak 3201012 2.0mm/2.4mmThreadedTak 3201210 1.0mmDrill,Manual 3201213 1.3mmDrill,Manual 3201215 1.5mmDrill,Manual 3201216 1.6mmDrill,Manual 3201220 2.0mmDrill,Manual 3201224 2.4mmDrill,Manual 3201410 1.0mmDrill,JLatch 3201413 1.3mmDrill,JLatch 3201415 1.5mmDrill,JLatch 3201416 1.6mmDrill,JLatch 3201420 2.0mmDrill,JLatch 3201424 2.4mmDrill,JLatch Page5of12
PartNo. PartDescription GMDN 3201610 1.0mmDrill,QuickRelease 3201613 1.3mmDrill,QuickRelease 3201615 1.5mmDrill,QuickRelease 3201616 1.6mmDrill,QuickRelease 3201620 2.0mmDrill,QuickRelease 3201624 2.4mmDrill,QuickRelease 3201715 1.5mmDrill,QuickRelease,Short 3201720 2.0mmDrill,QuickRelease,Short 3204011 2.5mmPilotDrill,Manual 3204310 2.5mmPilotDrill,OsteoPower 3210004 FPS PlateHoldingTak,.045"x6" 3210121 FPS PlateHoldingTak,.062"x6" 3231113 FPS 1.3mmfor2.0mmScrewPilotDrill 3231116 FPS 1.6mmfor2.7mmScrewPilotDrill 3231120 FPS 2.0mmfor2.7mmScrewPilotDrill 3231220 FPS 2.0mmClearanceDrillBit 3231224 FPS 2.4mmfor3.5/4.0ScrewsPilotDrill 3231227 FPS 2.7mmClearanceDrillBit 3231235 FPS 3.5mmClearanceDrillBit 3231240 FPS 4.0mmClearanceDrillBit 3231300 GuidePin 3231313 1.3mmJLatchFPSDrill,Short 3231320 2.0mmJLatchFPSDrill,Short 3231324 2.4mmJLatchFPSDrill,Short 3410005SP TalarFit10.5"KWire,Long,Sterile P34108 3411000SP LockingTalarFitSurgicalKitSterile 3602200 InterPhalangealSterileSurgicalKit 3602800 MetatarsalPhalangealSterileSurgicalKit 3800006 SingleUseBlades,SterilePacked,6pack 3800010 KobyGardSingleUseBlades,Sterile 450000500 PowerControlConsole2iwithIrrigation 450000501 PowerControlConsole2iwithIrrigation,EnglishVoice 450000502 PowerControlConsole2iwithIrrigation,ItalianVoice 450000503 PowerControlConsole2iwithIrrigation,SpanishVoice 450000504 PowerControlConsole2iwithIrrigation,FrenchVoice 450000505 PowerControlConsole2iwithIrrigation,GermanVoice 450002100 PowerControlConsole2 450002101 PowerControlConsole2,EnglishVoice 450002102 PowerControlConsole2,ItalianVoice 450002103 PowerControlConsole2,SpanishVoice 450002104 PowerControlConsole2,FrenchVoice 450002105 PowerControlConsole2,GermanVoice Page6of12
PartNo. PartDescription GMDN 4500030 ModularMotorUnitandCord 4500032 ModularMotorUnitandCordII 4500034 LeverArmMotorUnit 4500036 LeverArm 4500055 AUTODRIVER withcollet 4500056 AUTODRIVER Screwdriverfor1.6mmScrews 4500080 MotorUnit,FootswitchControl 4500082 LowProfileModularMotorUnit,FootswitchOnly 4500084 SeriesIILowProfileModularMotorUnit,FootswitchOnly 4500203 UniversalStraightDrillModule,HighSpeed 4500204 4:1UniversalPilotDrill 4500212 1:1StraightDrillModule,HighSpeed 4500214 1:1StraightDrill 4500215 1:1ContraAngleDrill 4500220 18:1ContraAngleDrill 4500222 18:1ContraAngleDrill,ExternalIrrigation 4500230 100:1ContraAngleDrill 4500232 100:1ContraAngleDrill,ExternalIrrigation 4500234 100:1ContraAngleDrill,LowSpeed,ExternalIrrigation 4500240 ReciprocatingSaw 4500241 QuickConnectReciprocatingSaw 4500255 SagittalSaw 4500261 OscillatingSaw 4500270 V.R.O.Saw 4500277SP V.R.O.SawBlade,12mm,.38mmThick,Sterile 4500278SP V.R.O.SawBlade,7mm,Sterile 4500279SP V.R.O.SawBlade,12mm,Sterile 4500285 Wire/PinDriver,BodyOnly 4500286 Wire/PinDriverModulewithTrigger,.028"1.25" 4500287 HighTorqueJacobsChuck(450028790Included) 4500289 SynthesA.O.ChuckAssembly 4500291 A.O.ChuckwithTrigger,030MU 4500296 Wire/PinDriverModule340o 4500300 WirePinDriverBody,LAMU 4500301 WirePinDriver,LAMU 4500302 JacobsChuck,LAMU 4500303 A.O.Chuck,LAMU 4500306 Wire/PinDriverModule340oLAMU 4500350 UniDirectionalFootswitchII 4500360 BiDirectionalFootswitchII 4500370 UniDirectionalMasterFootswitchII 4500380 BiDirectionalMasterFootswitchII Page7of12
PartNo. PartDescription GMDN 4500390 BMFFootswitch 4500425SP Blade,Sag/Osc4mm/25mm,Sterile 4500604 AutoTap,1.6mm,4mmStop,OsteoDriverTM 4500605 AutoTap,1.6mm,6mmStop,OsteoDriverTM 4500606 AutoTap,1.6mm,8mmStop,OsteoDriverTM 4500607 AutoTap,2.0mm,4mmStop,OsteoDriverTM 4500608 AutoTap,2.0,6mmStop,OsteoDriverTM 4500609 AutoTap,2.0,8mmStop,OsteoDriverTM 4500610.9mmPilotDrill,4mmStop,OsteoDriverTM 4500611.9mmPilotDrill,5mmStop,OsteoDriverTM 4500612.9mmPilotDrill,6mmStop,OsteoDriverTM 4500613.9mmPilotDrill,8mmStop,OsteoDriverTM 4500614 1.2mmPilotDrill,4mmStop,OsteoDriverTM 4500615 1.2mmPilotDrill,5mmStop,OsteoDriverTM 4500616 1.2mmPilotDrill,6mmStop,OsteoDriverTM 4500617 1.2mmPilotDrill,8mmStop,OsteoDriverTM 4500621 1.6mmPilotDrill,4mmStopDisposableAutoDriver 4500622 1.6mmPilotDrill,6mmStopDisposableAutoDriver 4500626 PilotDrill,.9x4mmStop,Extended,DisposableAutodriver 4500627 PilotDrill,.9x5mmStop,Extended,DisposableAutodriver 4500628 PilotDrill,.9x6mmStop,Extended,DisposableAutodriver 4500629 PilotDrill,.9x8mmStop,Extended,DisposableAutodriver 4500630 PilotDrill,1.2x4mmStop,Extended,DisposableAutodriver 4500631 PilotDrill,1.2x5mmStop,Extended,DisposableAutodriver 4500632 PilotDrill,1.2x6mmStop,Extended,DisposableAutodriver 4500633 PilotDrill,1.2x8mmStop.Extended,DisposableAutodriver 4500634 PilotDrill,1.6x4mmStop,Extended,DisposableAutodriver 4500635 PilotDrill,1.6x5mmStop,Extended,DisposableAutodriver 4500636 PilotDrill,1.6x6mmStopExtended,DisposableAutodriver 4500637 PilotDrill,1.6x8mmStop,Extended,DisposableAutodriver 4500638 PilotDrill,1.6x5mmStop,Extended,DisposableAutodriver 4500639 PilotDrill,1.6x8mmStop,Extended,DisposableAutodriver 4500718SP Blade,Sag/Osc7mm/18mm,Arced,Sterile 4500777 SeriesIIIStraightDrill 4501007 Blade,Sag/Osc10mm/7mm,Angled,BoneGrafting 4501007SP Blade,Sag/Osc10mm/7mm,Angled,BoneGrafting,Sterile 4501010 Blade,Sag/Osc10mm/10mm,Arced 4501010SP Blade,Sag/Osc10mm/10mm,Arced,Sterile 4501016 Blade,Sag,10mm/16mmBoneGrafting 4501016SP Blade,Sag,10mm/16mmBoneGrafting,Sterile 4501019 Blade,Sag/Osc10mm/19mm 4501019SP Blade,Sag/Osc10mm/19mm,Sterile Page8of12
PartNo. PartDescription GMDN 4501027 Blade,Sag/Osc10mm/27mm,Arced 4501027SP Blade,Sag/Osc10mm/27mm,Arced,Sterile 4501028 Blade,Sag/Osc10mm/28mm,Arced 4501028SP Blade,Sag/Osc10mm/28mm,Arced,Sterile 4501029 Blade,Sag/Osc10mm/29mm 4501029SP Blade,Sag/Osc10mm/29mm,Sterile 4501039SP Blade,Sag/Osc10mm/39mm,Arced,Sterile 4501231 Blade,VRO,Angled12mm/13mm 4501432 CrescenticBlade,14mmx32mm 4501605 Blade,Sag/Osc6mm/5mm 4501605SP Blade,Sag/Osc6mm/5mm,Sterile 4501610 Blade,Sag/Osc6mm/10mm 4501610SP Blade,Sag/Osc6mm/10mm,Sterile 4501614SP Blade,Sag/Osc6mm/14mm,Sterile 4501619 Blade,Sag/Osc6mm/19mm 4501619SP Blade,Sag/Osc6mm/19mm,Sterile 4501626 Blade,Sag/Osc6mm/26mm 4501626SP Blade,Sag/Osc6mm/26mm,Sterile 4501830 CrescenticBlade,18mmx30mm 4501912 CrescenticBlade,9mmx12mm 4501929SP Blade,Sag/Osc19mm/29mm,Arced,Sterile 4501941 Blade,Sag/Osc19mm/41mm,Arced 4501941SP Blade,Sag/Osc19mm/41mm,Arced,Sterile 4502012 Blade,Recip.,Arced,12mm,4mmStop 4502012SP Blade,Recip.,Arced,12mm,4mmStop,Sterile 4502013 Blade,Recip.,13.8mmCut 4502013SP Blade,Recip.,13.8mmCut,Sterile 4502015 Blade,Recip.,Mini,15.7mmCut 4502015SP Blade,Recip.,Mini,15.7mmCut,Sterile 4502026 Blade,Recip.,LongTapered,26.3mmCut 4502026SP Blade,Recip.,LongTapered,26.3mmCut,Sterile 4502032 Blade,Recip.,VRO,32.1mmCut 4502032SP Blade,Recip.,VRO,32.1mmCut,Sterile 4502033SP Blade,Recip.,Long32.7mmCut,Sterile 4502035 Blade,Recip.,ExtraLong,"HUR"Blade,MAR 4502035SP Blade,Recip.,ExtraLong,"HUR"Blade,MAR,Sterile 4502050 Rasp,Recip.,StraightCut 4502050SP Rasp,Recip.,StraightCut,Sterile 4502052 Rasp,Recip.,CrossCut 4502052SP Rasp,Recip.,CrossCut,Sterile 4502054 Rasp,Recip.,CrossCut,Short 4502054SP Rasp,Recip.,CrossCut,Short,Sterile Page9of12
PartNo. PartDescription GMDN 4502055 Rasp,Recip.,ExtraLong,13mmx17mm,Head,MAR 4502055SP Rasp,Recip.,ExtraLong,13mmx17mm,Head,MAR,Sterile 4502126 Blade,Recip.,ShortTapered,26.3mmCut 4502126SP Blade,Recip.,ShortTapered,26.3mmCut,Sterile 4502212 Blade,Recip.,Arced,12mm,4mmStop,.6mmThick 4502212SP Blade,Recip.,Arced,12mm,4mmStop,.6mmThick,Sterile 4502214SP Blade,Recip.,Arced,17mm,4mmStop,.6mmThick,Sterile 4502215 Blade,Recip.,Mini,15.7mmCut,.6mmThick 4502215SP Blade,Recip.,Mini,15.7mmCut,.6mmThick,Sterile 4502226 Blade,Recip.,LongTapered,.6mmThick 4502226SP Blade,Recip.,LongTapered,.6mmThick,Sterile 4502232 Blade,Recip.,VRO,.6mmThick 4502232SP Blade,Recip.,VRO,.6mmThick 4502233SP Blade,Recip.,Long,.6mmThick 4502326 Blade,Recip.,Long,.6mmThick 4502326SP Blade,Recip.,ShortTapered,.6mmThick,Sterile 4503001 Bur,#1/4Round,0.5mmx59mm 4503001SP Bur,#1/4Round,0.5mmx59mm,Sterile 4503004 Bur,#4Round,1.4mmx59mm 4503004SP Bur,#4Round,1.4mmx59mm,Sterile 4503006SP Bur,#6Round,1.8mmx59mm,Sterile 4503008SP Bur,#8Round,2.3mmx59mm,Sterile 4503010SP Bur,#10Round,2.7mmx59mm,Sterile 4503040 Bur,Round,4.0mmx59mm 4503040SP Bur,Round,4.0mmx59mm,Sterile 4503050 Bur,Round,5.0mmx59mm 4503050SP Bur,Round,5.0mmx59mm,Sterile 4503060 Bur,Round,6.0mmx59mm 4503060SP Bur,Round,6.0mmx59mm,Sterile 4503070 Bur,Round,7.0mmx59mm 4503070SP Bur,Round,7.0mmx59mm,Sterile 4503101 Drill,WirePassing,1.0mmx69mm 4503101SP Drill,WirePassing,1.0mmx69mm,Sterile 4503115 Drill,WirePassing,1.5mmx69mm 4503115SP Drill,WirePassing,1.5mmx69mm,Sterile 4503116 Bur,Lindemann,1.6mmx69mm 4503116SP Bur,Lindemann,1.6mmx69mm,Sterile 4503120 Drill,WirePassing,2.0mmx69mm 4503120SP Drill,WirePassing,2.0mmx69mm,Sterile 4503140 Bur,Oval,4.0mmx59mm 4503140SP Bur,Oval,4.0mmx59mm,Sterile 4503160 Bur,Pineapple,6.0mmx65mm Page10of12
PartNo. PartDescription GMDN 4503160SP Bur,Pineapple,6.0mmx65mm,Sterile 4503161SP Bur,ChristmasTree,4mmx72mm,Sterile 4503162SP SwansonPilotPointReamer,2.0mm,Sterile 4503164SP SwansonPilotPointReamer,3.0mm,Sterile 4503166SP SwansonPilotPoint,Reamer,4.0mm,Sterile 4503168SP SwansonPilotPoint,Reamer,5.0mm,Sterile 4503170SP ShannonBur,2.3mm,Sterile 4503701SP Bur,#7011.2mmx59mm,Sterile 4503702SP Bur,#7021.6mmx59mm,Sterile 4503703SP Bur,#7032.1mmx59mm,Sterile 4503713SP Bur,#17032.1mmx59mm,Sterile 4505008SP Bur,#8Round,2.3mmx65mm,Sterile 4505030 Bur,RoundDiamond,3.0mmx59mm 4505030SP Bur,RoundDiamond,3.0mmx59mm,Sterile 4505035 Bur,RoundDiamond,3.5mmx59mm 4505035SP Bur,RoundDiamond,3.5mmx59mm,Sterile 4505040 Bur,RoundDiamond,4.0mmx59mm 4505040SP Bur,RoundDiamond,4.0mmx59mm,Sterile 4505045 Bur,RoundDiamond,4.5mmx59mm 4505045SP Bur,RoundDiamond,4.5mmx59mm,Sterile 4505702SP Bur,#7021.6mmx65mm,Sterile 4505703SP Bur,#7032.1mmx65mm,Sterile 4505713SP Bur,#17032.1mmx65mm,Sterile 4506000 UniversalDiscAdapter(NonSterile) 4506003 OsteoGraftCuttingWheel,.25mmThick 4506003SP OsteoGraftCuttingWheel,.25mmThick,SterilePacked 4506005 OsteoGraftCuttingWheel,.5mmThick 4506005SP OsteoGraftCuttingWheel,.5mmThick,SterilePacked 4506116SP Bur,Lindemann,1.6mmx84mm,Sterile 4506118SP Bur,Lindemann,(455ST),1.6mmx84mm,Sterile 4506140 Bur,Oval,4.0mmx69mm 4506140SP Bur,Oval,4.0mmx69mm,Sterile 4506702SP Bur,#702LExtraLongBurHead,Sterile 4506703SP Bur,#703LExtraLongBurHead,Sterile 4506713SP Bur,#1703LExtraLongBurHead,Sterile 4508000 InferiorBorderBlades,RightandLeft 4508000SP InferiorBorderBlades,RightandLeft,Sterile 4512013SP 0.4mmx13.8mmReciprocatingSawBlade,LongShaft,Sterile 4512015SP 0.4mmx15.7mmReciprocatingSawBlade,LongShaft,Sterile 4512026SP 0.4mmx26.3mmReciprocatingSawBlade,LongShaft,Sterile 4512033SP 0.4mmx32.7mmReciprocatingSawBlade,LongShaft,Sterile 4512052SP CrossCutRasp,ReciprocatingSaw,LongShaft,Sterile Page11of12
PartNo. PartDescription GMDN 4512054SP CrossCutRasp,ReciprocatingSaw,ShortShaft,Sterile 4512126SP 0.4mmx26.3mmReciprocatingSawBlade,ShortShaft,Sterile 4512212SP 0.6mmx12.0mmArcedReciprocatingSawBlade,LongShaft,Sterile 4512214SP 0.6mmx17.0mmArcedReciprocatingSawBlade,LongShaft,Sterile 4512226SP 0.6mmx26.3mmReciprocatingSawBlade,LongShaft,Sterile 4512326SP 0.6mmx26.3mmReciprocatingSawBlade,ShortShaft,Sterile 4518000SP Left&RightInferiorBorderBlade,ReciprocatingSaw,Sterile 4553006 Bur,#6Round,1.8mmx59mm(5pack) 4553008 Bur,#8Round,2.3mmx59mm(5pack) 4553010 Bur,#10Round,2.7mmx59mm(5pack) 4553558 Bur,#5581.2mmx59mm(5pack) 4553560 Bur,#5601.6mmx59mm(5pack) 4553701 Bur,#7011.2mmx59mm(5pack) 4553702 Bur,#7021.6mmx59mm(5pack) 4553703 Bur,#7032.1mmx59mm(5pack) 4553713 Bur,#17032.1mmx59mm(5pack) 4554004 Bur,#4Round,1.4mmx26mm(5pack) 4554006 Bur,#6Round,1.8mmx26mm(5pack) 4554008 Bur,#8Round2.3mmx26mm(5pack) 4554701 #701,1.2mmx22.5mm(5pack) 4554702 #702,1.6mmx26mm(5pack) 4554703 #703,2.1mmx22.5mm(5pack) 4555008 Bur,#8Round,2.3mmx65mm(5pack) 4555702 Bur,#7021.6mmx65mm(5pack) 4555703 Bur,#7032.1mmx65mm(5pack) 4555713 Bur,#17032.1mmx65mm(5pack) 4556006 Bur,#6Round,1.8mmx59mm,6Flute(5pack) 4556702 Bur,#702ExtraLongBurHead(5pack) 4556703 Bur,#703ExtraLongBurHead(5pack) 4556713 Bur,#1703LExtraLongBurHead(5pack) 4557702 #702Long,1.6mmx33mm(5pack) 4557703 #703Long,2.1mmx33mm(5pack) 8000206 PrimaLOKTMSP14mmDistractorScrew 8000206SP PrimaLOKTMSP14mmDistractorScrews,Sterile2Pack 8001200 PrimaLOK FFGuideWire 8001207 PrimaLOK FFAccessNeedle 8001208 PrimaLOK FFSingleBevelAccessNeedle 8001209 PrimaLOK FFTrocarTipAccessNeedle 8001212 PrimaLOK FFThreadedImplantDriverShaftCannulated Page12of12