Declaration of Conformity

Transcription

1 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 Kitemark Court, Davy Avenue, Knowhill, Milton Keynes MK5 SPP (Notified under No 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/ Customer Service: 800/ Arapaho Road Addison, TX 75001, USA Fishbourne, Chichester 25 Baker Close Tet: +44 (0) OsteoMed Shotwelt SL Carr Manufacturer: European Authorized Representative: West Sussex, UK P018 8BJ

2 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/ West Sussex, UK P018 8BJ Mimo USA: 972/ Tel.: +44(0) 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 Platný do: Čísla šarží a/alebo výrobné čísla výrobkov v zásielke, ktoré podliehajú tomuto vyhláseniu, sú k dispozícií na vyžiadanie. Zástupca vedenia spoločnosti OsteoMed: Podpis nečitateľný Bill Melendez, PE Dátum Prevádzkový riaditel Vyhlásenie o zhode ha

3 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 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 -

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5 DeclarationofConformityClassIIaPartsListing PartNo. PartDescription GMDN mmLockingScrewBendingInsert mmLockingScrewBendingInsert gaugeStainlessSteelWire P T 15mm,"L"Template T 18mm,Right"L"Template T 23mmRight"L",Template T 18HoleStraightPlate,Template T 33mm4HoleSemiCompressionTemplate T 33mm4HoleEDCTemplate T 48mm6HoleEDCTemplate T 38mm4HoleEDCTemplate T ShortAngledEDCTemplate T LongAngledEDCTemplate T RightReconstructionTemplate T StraightReconstructionTemplate T ReconstructionTemplate4x12Hole, T ReconstructionTemplate5x16Hole T ReconstructionTemplate,Full,5x20x T ReconstructionTemplate,Full,5x20x T ReconstructionTemplate,Straight,14Hole T ReconstructionTemplate,Straight,18Hole T FractureTemplate,4HoleDCP,32mm T FractureTemplate,4HoleDCP,34mm T FractureTemplate,4HoleDCP,37mm T FractureTemplate,6HoleDCP,47mm T FractureTemplate,6HoleDCP,49mm T FractureTemplate,6HoleDCP,52mm T FractureTemplate,8HoleDCP,59mm T 2x2HoleAngledFracturePlateTemplate T 3x3HoleAngledFracturePlateTemplate T RigidComminutedFracturePlateTemplate T MFx 2.0mmReductionTemplate,4Hole T MFx 2.4mmReductionTemplate,4Hole T MFx 125 ContouredReconstructionTemplate,4x12,Right&Left T MFx 125 ContouredReconstructionTemplate,5x16,Right&Left T MFx 125 ContouredReconstructionTemplate,5x20x5,Full T MFx 125 ContouredReconstructionTemplate,5x16x5,Full T 2.0mmLockingFracturePlate,4Hole,Short,Template T 2.0mmLockingFracturePlate,4Hole,Medium,Template Page1of12

6 PartNo. PartDescription GMDN T 2.0mmLockingFracturePlate,6Hole,Template T 2.0mmLockingPlate,Comminution,Template mmPilotDrill,LogicTMJr.OsteoPower mmPilotDrill,LogicTMJr.,JLatch mmPilotDrill,JLatch mmPilotDrill,JLatch mmPilotDrill,JLatch,12mm mmPilotDrill,JLatch mmPilotDrill,Long,JLatch mmPilotDrill,JLatch,12mm mmPilotDrill,Long,JLatch mmPilotDrill,Manual mmPilotDrill,Manual mmPilotDrill,4mmStop,JLatch mmPilotDrill,6mmStop,JLatch mmPilotDrill,4mmStop,JLatch mmPilotDrill,3mmStop,JLatch mmPilotDrill,JLatch,16mm mmPilotDrill,Manual mmPilotDrill,DentalLatch mmPilotDrill,8mmStop,DentalLatch mmPilotDrill,4mmStop,DentalLatch mmPilotDrill,6mmStop,JLatch mmPilotDrill,4mmStop,JLatch mmPilotDrill,4mmStop,Manual mmPilotDrill,Stryker100kCommand mmPilotDrill,16mm,DentalLatch mmCalibratedDrillBit,DLatch mmPilotDrill,16mm,DentalLatch mmPilotDrill,16mm,DentalLatch mmPilotDrill,Calibrated,LongPointedCannula,JLatch mmPilotDrill,Calibrated,LongPointedCannula,JLatch mmPilotDrill,Calibrated,LongPointedCannula,OsteoPower mmPilotDrill,DentalLatch mmPilotDrill,10mm,DentalLatch mmPilotDrill,6mm,DentalLatch mmTwistDrill,4mmStop,Short,DentalLatch mmTwistDrill,6mmStop,Short,DentalLatch mmPilotDrill,12mmStop,DentalLatch mmPilotDrill,Calibrated,ShortPointedCannula,JLatch mmPilotDrill,LongCalibrated,JLatch mmPilotDrill,Calibrated,ShortPointedCannula,JLatch Page2of12

7 PartNo. PartDescription GMDN mmPilotDrill,LongCalibrated,JLatch mmPilotDrill,JLatch,ExtendedLength MFx 1.6mmRainbowPilotDrill,ShortPointedCannula,JLatch MFx 2.0mmRainbowPilotDrill,ShortPointedCannula,JLatch MFx 1.6mmRainbowPilotDrill,LongPointedCannula,JLatch MFx 2.0mmRainbowPilotDrill,LongPointedCannula,JLatch MFx 1.6mmRainbowPilotDrill,BluntCannula,JLatch MFx 2.0mmRainbowPilotDrill,BluntCannula,JLatch mmPilotDrill,OSTEOPOWERTM mmPilotDrill,OSTEOPOWERTM mmPilotDrill,12mmStop,OSTEOPOWER mmPilotDrill,OSTEOPOWER mmPilotDrill,Long,OSTEOPOWER mmPilotDrill,OSTEOPOWER mmPilotDrill,Long,OSTEOPOWER mmPilotDrill,Calibrated,Mandible,OSTEOPOWER PilotDrill,OsteoPowerMaxi,LongCalibrated,2.0mm mmPilotDrill,ExtendedLength,OSTEOPOWER mmPilotDrill,Long,OSTEOPOWER mmPilotDrill,4mmStop,OSTEOPOWERTM mmPilotDrill,6mmStop,OSTEOPOWER mmPilotDrill,4mmStop,OSTEOPOWER mmPilotDrill,8mmStop,OsteoPower mmPilotDrill,3mmStop,JLatch mmPilotDrill,4mmStop,JLatch mmPilotDrill,5mmStop,JLatch mmPilotDrill6mmStopRobust mmPilotDrill,14mm,OsteoPower mmPilotDrill,18mm,OsteoPower mmPilotDrill,OsteoPower mmPilotDrill,OsteoPower mmPilotDrill,16mmStop,OsteoPower mmPilotDrill,Long,MandibleSystem mmPilotDrill,Long,MandibleSystem mmPilotDrill,Long,MandibleSystem,OSTEOPOWER mmPilotDrill,Mandible,OSTEOPOWER mmTwistDrill,16mmStop,JLatch mmPilotDrill,8mmStop mmPilotDrill,12mmStop mmPilotDrill,8mmStop mmPilotDrill,22mmStop mmPilotDrill,4mmStop,Jlatch Page3of12

8 PartNo. PartDescription GMDN mmPilotDrill,4mmStop,Manual mmPilotDrill,6mmStop,Jlatch mmPilotDrill,3MLatch,4mmStop mmPilotDrill,3MLatch,6mmStop mmPilotDrill,4mmStop mmPilotDrill,6mmStop mmPilotDrill,4mmStop,OsteoPower mmPilotDrill,6mmStop,OsteoPower ContraAngleDisposableSet,7mmPlunge,3pc ContraAngleDisposableSet,11mmPlunge,3pc mmPilotDrill,4mmStop,JLatch mmPilotDrill,6mmStop,JLatch mmPilotDrill,8mmStop,JLatch mmPilotDrill,8mmStop,OsteoPower mmPilotDrill,6mmStop,OsteoPower mmPilotDrill,4mmStop,OsteoPower AutoTap,1.6mm,4mmStop,AutoDriver AutoTap,1.6mm,6mmStop,AutoDriver AutoTap,1.6mm,8mmStop,AutoDriver AutoTap,2.0mm,4mmStop,AutoDriver AutoTap,2.0mm,8mmStop,AutoDriver AutoTap,2.0mm,8mmStop,AutoDriver T CalFix,CalcanealPlateTemplate,56mm T CalFix,CalcanealPlateTemplate,65mm T CalFix,CalcanealPlateTemplate,74mm mmCannulatedDrill,Manual mmCannulatedDrill,QuickRelease mmCannulatedDrill,Long,QuickRelease mmCannulatedDrill,QuickRelease mmCannulatedDrill x11.8"PartiallyThreadedSteinmannPin mmCannulatedDrill,Manual x4"GuideWire P mmCannulatedDrill,Long,Manual mmPilotDrill,Cannulated,QuickRelease mmDrill/CountersinkCombo,Short,Manual mmDrill/CountersinkCombo,Long,Manual mmDrill/Countersink,Short,Manual mmDrill/Countersink,Long,Manual /2.4mmProximalCortexDrill mmProximalCortexDrill,Manual /2.4mmProximalCortexDrill,QuickRelease Page4of12

9 PartNo. PartDescription GMDN mmProximalCortexDrill,QuickRelease mmProximalCortexDrill,Manual mmProximalCortexDrill,QuickRelease mmCannulatedDrill,Manual mmCannulatedDrill,QuickRelease mmCannulatedDrill,Fusion,Manual mmCannulatedDrill,Fusion,Manual mmCannulatedDrill,Fusion,QuickRelease mmCannulatedDrill,Fusion,QuickRelease mmPilotDrill,JLatch mmPilotDrill,JLatch mmPilotDrill,JLatch mmPilotDrill,JLatch mmPilotDrill,Manual mmPilotDrill,Manual mmPilotDrill,Manual mmPilotDrill,Manual mmPilotDrill,QuickRelease mmPilotDrill,QuickRelease mmScrewPilotDrillAssy mmPilotDrill,OsteoPower mmPilotDrill,OsteoPower mmPilotDrill,OsteoPower mmx228mmSteinmannPin,FullyThreaded mmx229mmSteinmannPin,Smooth mmx229mmSteinmannPin,PartiallyThreaded mm/1.6mmPlateHoldingTak mm/2.4mmPlateHoldingTak mm/1.6mmThreadedTak mm/2.4mmThreadedTak mmDrill,Manual mmDrill,Manual mmDrill,Manual mmDrill,Manual mmDrill,Manual mmDrill,Manual mmDrill,JLatch mmDrill,JLatch mmDrill,JLatch mmDrill,JLatch mmDrill,JLatch mmDrill,JLatch Page5of12

10 PartNo. PartDescription GMDN mmDrill,QuickRelease mmDrill,QuickRelease mmDrill,QuickRelease mmDrill,QuickRelease mmDrill,QuickRelease mmDrill,QuickRelease mmDrill,QuickRelease,Short mmDrill,QuickRelease,Short mmPilotDrill,Manual mmPilotDrill,OsteoPower FPS PlateHoldingTak,.045"x6" FPS PlateHoldingTak,.062"x6" FPS 1.3mmfor2.0mmScrewPilotDrill FPS 1.6mmfor2.7mmScrewPilotDrill FPS 2.0mmfor2.7mmScrewPilotDrill FPS 2.0mmClearanceDrillBit FPS 2.4mmfor3.5/4.0ScrewsPilotDrill FPS 2.7mmClearanceDrillBit FPS 3.5mmClearanceDrillBit FPS 4.0mmClearanceDrillBit GuidePin mmJLatchFPSDrill,Short mmJLatchFPSDrill,Short mmJLatchFPSDrill,Short SP TalarFit10.5"KWire,Long,Sterile P SP LockingTalarFitSurgicalKitSterile InterPhalangealSterileSurgicalKit MetatarsalPhalangealSterileSurgicalKit SingleUseBlades,SterilePacked,6pack KobyGardSingleUseBlades,Sterile PowerControlConsole2iwithIrrigation PowerControlConsole2iwithIrrigation,EnglishVoice PowerControlConsole2iwithIrrigation,ItalianVoice PowerControlConsole2iwithIrrigation,SpanishVoice PowerControlConsole2iwithIrrigation,FrenchVoice PowerControlConsole2iwithIrrigation,GermanVoice PowerControlConsole PowerControlConsole2,EnglishVoice PowerControlConsole2,ItalianVoice PowerControlConsole2,SpanishVoice PowerControlConsole2,FrenchVoice PowerControlConsole2,GermanVoice Page6of12

11 PartNo. PartDescription GMDN ModularMotorUnitandCord ModularMotorUnitandCordII LeverArmMotorUnit LeverArm AUTODRIVER withcollet AUTODRIVER Screwdriverfor1.6mmScrews MotorUnit,FootswitchControl LowProfileModularMotorUnit,FootswitchOnly SeriesIILowProfileModularMotorUnit,FootswitchOnly UniversalStraightDrillModule,HighSpeed :1UniversalPilotDrill :1StraightDrillModule,HighSpeed :1StraightDrill :1ContraAngleDrill :1ContraAngleDrill :1ContraAngleDrill,ExternalIrrigation :1ContraAngleDrill :1ContraAngleDrill,ExternalIrrigation :1ContraAngleDrill,LowSpeed,ExternalIrrigation ReciprocatingSaw QuickConnectReciprocatingSaw SagittalSaw OscillatingSaw V.R.O.Saw SP V.R.O.SawBlade,12mm,.38mmThick,Sterile SP V.R.O.SawBlade,7mm,Sterile SP V.R.O.SawBlade,12mm,Sterile Wire/PinDriver,BodyOnly Wire/PinDriverModulewithTrigger,.028"1.25" HighTorqueJacobsChuck( Included) SynthesA.O.ChuckAssembly A.O.ChuckwithTrigger,030MU Wire/PinDriverModule340o WirePinDriverBody,LAMU WirePinDriver,LAMU JacobsChuck,LAMU A.O.Chuck,LAMU Wire/PinDriverModule340oLAMU UniDirectionalFootswitchII BiDirectionalFootswitchII UniDirectionalMasterFootswitchII BiDirectionalMasterFootswitchII Page7of12

12 PartNo. PartDescription GMDN BMFFootswitch SP Blade,Sag/Osc4mm/25mm,Sterile AutoTap,1.6mm,4mmStop,OsteoDriverTM AutoTap,1.6mm,6mmStop,OsteoDriverTM AutoTap,1.6mm,8mmStop,OsteoDriverTM AutoTap,2.0mm,4mmStop,OsteoDriverTM AutoTap,2.0,6mmStop,OsteoDriverTM AutoTap,2.0,8mmStop,OsteoDriverTM mmPilotDrill,4mmStop,OsteoDriverTM mmPilotDrill,5mmStop,OsteoDriverTM mmPilotDrill,6mmStop,OsteoDriverTM mmPilotDrill,8mmStop,OsteoDriverTM mmPilotDrill,4mmStop,OsteoDriverTM mmPilotDrill,5mmStop,OsteoDriverTM mmPilotDrill,6mmStop,OsteoDriverTM mmPilotDrill,8mmStop,OsteoDriverTM mmPilotDrill,4mmStopDisposableAutoDriver mmPilotDrill,6mmStopDisposableAutoDriver PilotDrill,.9x4mmStop,Extended,DisposableAutodriver PilotDrill,.9x5mmStop,Extended,DisposableAutodriver PilotDrill,.9x6mmStop,Extended,DisposableAutodriver PilotDrill,.9x8mmStop,Extended,DisposableAutodriver PilotDrill,1.2x4mmStop,Extended,DisposableAutodriver PilotDrill,1.2x5mmStop,Extended,DisposableAutodriver PilotDrill,1.2x6mmStop,Extended,DisposableAutodriver PilotDrill,1.2x8mmStop.Extended,DisposableAutodriver PilotDrill,1.6x4mmStop,Extended,DisposableAutodriver PilotDrill,1.6x5mmStop,Extended,DisposableAutodriver PilotDrill,1.6x6mmStopExtended,DisposableAutodriver PilotDrill,1.6x8mmStop,Extended,DisposableAutodriver PilotDrill,1.6x5mmStop,Extended,DisposableAutodriver PilotDrill,1.6x8mmStop,Extended,DisposableAutodriver SP Blade,Sag/Osc7mm/18mm,Arced,Sterile SeriesIIIStraightDrill Blade,Sag/Osc10mm/7mm,Angled,BoneGrafting SP Blade,Sag/Osc10mm/7mm,Angled,BoneGrafting,Sterile Blade,Sag/Osc10mm/10mm,Arced SP Blade,Sag/Osc10mm/10mm,Arced,Sterile Blade,Sag,10mm/16mmBoneGrafting SP Blade,Sag,10mm/16mmBoneGrafting,Sterile Blade,Sag/Osc10mm/19mm SP Blade,Sag/Osc10mm/19mm,Sterile Page8of12

13 PartNo. PartDescription GMDN Blade,Sag/Osc10mm/27mm,Arced SP Blade,Sag/Osc10mm/27mm,Arced,Sterile Blade,Sag/Osc10mm/28mm,Arced SP Blade,Sag/Osc10mm/28mm,Arced,Sterile Blade,Sag/Osc10mm/29mm SP Blade,Sag/Osc10mm/29mm,Sterile SP Blade,Sag/Osc10mm/39mm,Arced,Sterile Blade,VRO,Angled12mm/13mm CrescenticBlade,14mmx32mm Blade,Sag/Osc6mm/5mm SP Blade,Sag/Osc6mm/5mm,Sterile Blade,Sag/Osc6mm/10mm SP Blade,Sag/Osc6mm/10mm,Sterile SP Blade,Sag/Osc6mm/14mm,Sterile Blade,Sag/Osc6mm/19mm SP Blade,Sag/Osc6mm/19mm,Sterile Blade,Sag/Osc6mm/26mm SP Blade,Sag/Osc6mm/26mm,Sterile CrescenticBlade,18mmx30mm CrescenticBlade,9mmx12mm SP Blade,Sag/Osc19mm/29mm,Arced,Sterile Blade,Sag/Osc19mm/41mm,Arced SP Blade,Sag/Osc19mm/41mm,Arced,Sterile Blade,Recip.,Arced,12mm,4mmStop SP Blade,Recip.,Arced,12mm,4mmStop,Sterile Blade,Recip.,13.8mmCut SP Blade,Recip.,13.8mmCut,Sterile Blade,Recip.,Mini,15.7mmCut SP Blade,Recip.,Mini,15.7mmCut,Sterile Blade,Recip.,LongTapered,26.3mmCut SP Blade,Recip.,LongTapered,26.3mmCut,Sterile Blade,Recip.,VRO,32.1mmCut SP Blade,Recip.,VRO,32.1mmCut,Sterile SP Blade,Recip.,Long32.7mmCut,Sterile Blade,Recip.,ExtraLong,"HUR"Blade,MAR SP Blade,Recip.,ExtraLong,"HUR"Blade,MAR,Sterile Rasp,Recip.,StraightCut SP Rasp,Recip.,StraightCut,Sterile Rasp,Recip.,CrossCut SP Rasp,Recip.,CrossCut,Sterile Rasp,Recip.,CrossCut,Short SP Rasp,Recip.,CrossCut,Short,Sterile Page9of12

14 PartNo. PartDescription GMDN Rasp,Recip.,ExtraLong,13mmx17mm,Head,MAR SP Rasp,Recip.,ExtraLong,13mmx17mm,Head,MAR,Sterile Blade,Recip.,ShortTapered,26.3mmCut SP Blade,Recip.,ShortTapered,26.3mmCut,Sterile Blade,Recip.,Arced,12mm,4mmStop,.6mmThick SP Blade,Recip.,Arced,12mm,4mmStop,.6mmThick,Sterile SP Blade,Recip.,Arced,17mm,4mmStop,.6mmThick,Sterile Blade,Recip.,Mini,15.7mmCut,.6mmThick SP Blade,Recip.,Mini,15.7mmCut,.6mmThick,Sterile Blade,Recip.,LongTapered,.6mmThick SP Blade,Recip.,LongTapered,.6mmThick,Sterile Blade,Recip.,VRO,.6mmThick SP Blade,Recip.,VRO,.6mmThick SP Blade,Recip.,Long,.6mmThick Blade,Recip.,Long,.6mmThick SP Blade,Recip.,ShortTapered,.6mmThick,Sterile Bur,#1/4Round,0.5mmx59mm SP Bur,#1/4Round,0.5mmx59mm,Sterile Bur,#4Round,1.4mmx59mm SP Bur,#4Round,1.4mmx59mm,Sterile SP Bur,#6Round,1.8mmx59mm,Sterile SP Bur,#8Round,2.3mmx59mm,Sterile SP Bur,#10Round,2.7mmx59mm,Sterile Bur,Round,4.0mmx59mm SP Bur,Round,4.0mmx59mm,Sterile Bur,Round,5.0mmx59mm SP Bur,Round,5.0mmx59mm,Sterile Bur,Round,6.0mmx59mm SP Bur,Round,6.0mmx59mm,Sterile Bur,Round,7.0mmx59mm SP Bur,Round,7.0mmx59mm,Sterile Drill,WirePassing,1.0mmx69mm SP Drill,WirePassing,1.0mmx69mm,Sterile Drill,WirePassing,1.5mmx69mm SP Drill,WirePassing,1.5mmx69mm,Sterile Bur,Lindemann,1.6mmx69mm SP Bur,Lindemann,1.6mmx69mm,Sterile Drill,WirePassing,2.0mmx69mm SP Drill,WirePassing,2.0mmx69mm,Sterile Bur,Oval,4.0mmx59mm SP Bur,Oval,4.0mmx59mm,Sterile Bur,Pineapple,6.0mmx65mm Page10of12

15 PartNo. PartDescription GMDN SP Bur,Pineapple,6.0mmx65mm,Sterile SP Bur,ChristmasTree,4mmx72mm,Sterile SP SwansonPilotPointReamer,2.0mm,Sterile SP SwansonPilotPointReamer,3.0mm,Sterile SP SwansonPilotPoint,Reamer,4.0mm,Sterile SP SwansonPilotPoint,Reamer,5.0mm,Sterile SP ShannonBur,2.3mm,Sterile SP Bur,#7011.2mmx59mm,Sterile SP Bur,#7021.6mmx59mm,Sterile SP Bur,#7032.1mmx59mm,Sterile SP Bur,# mmx59mm,Sterile SP Bur,#8Round,2.3mmx65mm,Sterile Bur,RoundDiamond,3.0mmx59mm SP Bur,RoundDiamond,3.0mmx59mm,Sterile Bur,RoundDiamond,3.5mmx59mm SP Bur,RoundDiamond,3.5mmx59mm,Sterile Bur,RoundDiamond,4.0mmx59mm SP Bur,RoundDiamond,4.0mmx59mm,Sterile Bur,RoundDiamond,4.5mmx59mm SP Bur,RoundDiamond,4.5mmx59mm,Sterile SP Bur,#7021.6mmx65mm,Sterile SP Bur,#7032.1mmx65mm,Sterile SP Bur,# mmx65mm,Sterile UniversalDiscAdapter(NonSterile) OsteoGraftCuttingWheel,.25mmThick SP OsteoGraftCuttingWheel,.25mmThick,SterilePacked OsteoGraftCuttingWheel,.5mmThick SP OsteoGraftCuttingWheel,.5mmThick,SterilePacked SP Bur,Lindemann,1.6mmx84mm,Sterile SP Bur,Lindemann,(455ST),1.6mmx84mm,Sterile Bur,Oval,4.0mmx69mm SP Bur,Oval,4.0mmx69mm,Sterile SP Bur,#702LExtraLongBurHead,Sterile SP Bur,#703LExtraLongBurHead,Sterile SP Bur,#1703LExtraLongBurHead,Sterile InferiorBorderBlades,RightandLeft SP InferiorBorderBlades,RightandLeft,Sterile SP 0.4mmx13.8mmReciprocatingSawBlade,LongShaft,Sterile SP 0.4mmx15.7mmReciprocatingSawBlade,LongShaft,Sterile SP 0.4mmx26.3mmReciprocatingSawBlade,LongShaft,Sterile SP 0.4mmx32.7mmReciprocatingSawBlade,LongShaft,Sterile SP CrossCutRasp,ReciprocatingSaw,LongShaft,Sterile Page11of12

16 PartNo. PartDescription GMDN SP CrossCutRasp,ReciprocatingSaw,ShortShaft,Sterile SP 0.4mmx26.3mmReciprocatingSawBlade,ShortShaft,Sterile SP 0.6mmx12.0mmArcedReciprocatingSawBlade,LongShaft,Sterile SP 0.6mmx17.0mmArcedReciprocatingSawBlade,LongShaft,Sterile SP 0.6mmx26.3mmReciprocatingSawBlade,LongShaft,Sterile SP 0.6mmx26.3mmReciprocatingSawBlade,ShortShaft,Sterile SP Left&RightInferiorBorderBlade,ReciprocatingSaw,Sterile Bur,#6Round,1.8mmx59mm(5pack) Bur,#8Round,2.3mmx59mm(5pack) Bur,#10Round,2.7mmx59mm(5pack) Bur,#5581.2mmx59mm(5pack) Bur,#5601.6mmx59mm(5pack) Bur,#7011.2mmx59mm(5pack) Bur,#7021.6mmx59mm(5pack) Bur,#7032.1mmx59mm(5pack) Bur,# mmx59mm(5pack) Bur,#4Round,1.4mmx26mm(5pack) Bur,#6Round,1.8mmx26mm(5pack) Bur,#8Round2.3mmx26mm(5pack) #701,1.2mmx22.5mm(5pack) #702,1.6mmx26mm(5pack) #703,2.1mmx22.5mm(5pack) Bur,#8Round,2.3mmx65mm(5pack) Bur,#7021.6mmx65mm(5pack) Bur,#7032.1mmx65mm(5pack) Bur,# mmx65mm(5pack) Bur,#6Round,1.8mmx59mm,6Flute(5pack) Bur,#702ExtraLongBurHead(5pack) Bur,#703ExtraLongBurHead(5pack) Bur,#1703LExtraLongBurHead(5pack) #702Long,1.6mmx33mm(5pack) #703Long,2.1mmx33mm(5pack) PrimaLOKTMSP14mmDistractorScrew SP PrimaLOKTMSP14mmDistractorScrews,Sterile2Pack PrimaLOK FFGuideWire PrimaLOK FFAccessNeedle PrimaLOK FFSingleBevelAccessNeedle PrimaLOK FFTrocarTipAccessNeedle PrimaLOK FFThreadedImplantDriverShaftCannulated Page12of12