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The GAP Nail Endo-Exo Medullary System

EUDAMEDFDA UDI

Class I (EU MDR)

Ref GAP-SLS155Model SLEEVERef GAP-CS3-70Model CORTICAL SCREWRef GAP-CS3-24Ref GAP-CS4-38Ref GAP-PLL100Model PLATERef GAP-TGD200Model TARGETING DEVICERef GAP-LG095Ref GAP-PLC110Ref GAP-CS4-75Ref GAP-CS3-32Ref GAP-N72-16Model NAILRef GAP-CS4-26Ref GAP-N72-24Ref GAP-LG085Ref GAP-LG080Ref GAP-N80-28Ref GAP-N48-28Ref GAP-N64-24Ref GAP-INE200Model EMPTY LAG INSTRUMENTS CASERef GAP-CP050Model NAIL CAPRef GAP-CS4-34Ref GAP-CS4-80Ref GAP-PLC130Ref GAP-N64-18Ref GAP-CS3-30Ref GAP-N64-28Ref GAP-DCS102-LModel SCREW DRILLRef GAP-KWG020Model GUIDE WIRERef GAP-LG100Ref GAP-DCA272Model CANAL REAMERRef GAP-MPW200Model SCREWDRIVERRef GAP-IME250Model EMPTY IMPLANT CASERef GAP-PLS100Ref GAP-CS4-24Ref GAP-CS3-28Ref GAP-N56-26Ref GAP-N48-32Ref GAP-N56-20Ref GAP-CS3-38Ref GAP-LG070Ref GAP-N64-16Ref GAP-CS4-30Ref GAP-LG050Ref GAP-LG065Ref GAP-N64-30Ref GAP-MS24Ref GAP-DCS104-LRef GAP-DCA048Ref GAP-LG110Ref GAP-N80-30Ref GAP-CS2-60Ref GAP-DCA248Ref GAP-CS2-70Ref GAP-N72-20Ref GAP-N80-32Ref GAP-LG075Ref GAP-KDG360-PKG2Model LAG WIRERef GAP-N56-18Ref GAP-N56-16Ref GAP-CS4-70Ref GAP-LG055Ref GAP-DCS102Ref GAP-CS4-32Ref GAP-LG060Ref GAP-CS3-40Ref GAP-CS3-55Ref GAP-N64-20Ref GAP-CS3-22Ref GAP-DMS200Model LAG REAMERRef GAP-CS4-40Ref GAP-DCS204Ref GAP-KWG016-PKG6Ref GAP-N56-28Ref GAP-IME200Ref GAP-N72-18Ref GAP-DLG255Ref GAP-DCA064Ref GAP-CS3-50Ref GAP-N56-30Ref GAP-KWG016-PKG2Ref GAP-CS4-20Ref GAP-DTP200Model CONICAL REAMERRef GAP-DCA056Ref GAP-DCE100Model ENDMILLRef GAP-CS4-28Ref GAP-DCA256Ref GAP-N72-28Ref GAP-KDG360-PKG6Ref GAP-MSD204Ref GAP-CS2-65Ref GAP-N48-18Ref GAP-CS4-55Ref GAP-CS4-22Ref GAP-CS3-80

by OrthoPediatrics Canada ULC

Identity

Trade Name
The GAP Nail Endo-Exo Medullary System EUDAMED
GAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
Generic Name
Cannulated surgical drill bit, reusable FDA UDI
Surgical instrument/implant rack FDA UDI
Arthrodesis intramedullary nail, non-distracting FDA UDI
Orthopaedic bone screw (non-sliding) FDA UDI
Bone nail end-cap FDA UDI
Orthopaedic guidewire, single-use FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Surgical drill guide, reusable FDA UDI
Surgical torque wrench, reusable FDA UDI
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Implantable orthopaedic/craniofacial device connection screw FDA UDI
Device Name
GAP CANAL REAMER Ø6.4mm FDA UDI
GAP 2.0 EMPTY INSTRUMENTS CASE FDA UDI
GAP 2.0 EMPTY IMPLANT CASE 1 - NAIL FDA UDI
Nail Ø4.8mm X 320mm FDA UDI
Nail Ø8.0mm X 300mm FDA UDI
Nail Ø8.0mm X 280mm FDA UDI
Cortical Screw Ø4.0mm X 20mm FDA UDI
Lag Screw Ø5.5mm X 80mm FDA UDI
Nail Ø5.6mm X 160mm FDA UDI
GAP CANAL REAMER Ø4.8mm FDA UDI
Nail Ø6.4mm X 180mm FDA UDI
Nail Ø5.6mm X 280mm FDA UDI
Cortical Screw Ø3.0mm X 24mm FDA UDI
Cortical Screw Ø4.0mm X 22mm FDA UDI
Nail Ø5.6mm X 180mm FDA UDI
Lag Screw Ø5.5mm X 60mm FDA UDI
Nail Ø5.6mm X 300mm FDA UDI
GAP 2.0 CANAL REAMER Ø7.2mm FDA UDI
Cortical Screw Ø4.0mm X 75mm FDA UDI
Nail Cap 5.0mm High FDA UDI
GAP DEPTH GAGE WIRE Ø2.0mm x 360mm - PKG OF 6 FDA UDI
GAP CORTICAL SCREW DRILL Ø2.5mm FDA UDI
GAP 2.0 EMPTY IMPANT CASE 2 - COMPONENTS FDA UDI
Nail Ø8.0mm X 320mm FDA UDI
GAP GUIDE WIRE Ø1.6mm - PKG OF 6 FDA UDI
GAP CORTICAL SCREW DRILL-LONG Ø4.0mm FDA UDI
Cortical Peg Ø2.5mm X 70mm FDA UDI
Nail Ø7.2mm X 200mm FDA UDI
Cortical Screw Ø3.0mm X 38mm FDA UDI
GAP CORTICAL SCREW DRILL-LONG Ø2.5mm FDA UDI
GAP CANAL REAMER Ø5.6mm FDA UDI
Cortical Screw Ø3.0mm X 50mm FDA UDI
Cortical Screw Ø3.0mm X 32mm FDA UDI
Cortical Screw Ø4.0mm X 40mm FDA UDI
Coxa Vara Plate Small FDA UDI
Nail Ø6.4mm X 200mm FDA UDI
Nail Ø6.4mm X 160mm FDA UDI
Cortical Screw Ø3.0mm X 22mm FDA UDI
Cortical Screw Ø4.0mm X 30mm FDA UDI
Cortical Screw Ø4.0mm X 34mm FDA UDI
Short Fixation Plate FDA UDI
GAP 2.0 LAG REAMER FDA UDI
GAP LAG SCREW SLEEVE FDA UDI
Cortical Screw Ø3.0mm X 30mm FDA UDI
Long Fixation Plate FDA UDI
GAP GUIDE WIRE Ø2.0mm x 457mm FDA UDI
Cortical Screw Ø3.0mm X 28mm FDA UDI
GAP GUIDE WIRE Ø1.6mm - PKG OF 2 FDA UDI
Nail Ø7.2mm X 180mm FDA UDI
Cortical Screw Ø3.0mm X 70mm FDA UDI
Coxa Vara Plate Large FDA UDI
Lag Screw Ø5.5mm X 75mm FDA UDI
Cortical Screw Ø4.0mm X 32mm FDA UDI
Lag Screw Ø5.5mm X 85mm FDA UDI
Cortical Screw Ø4.0mm X 26mm FDA UDI
Lag Screw Ø5.5mm X 95mm FDA UDI
GAP 2.0 MULTIPURPOSE WRENCH FDA UDI
GAP 2.0 MECHANICAL SCREW DRILL FDA UDI
GAP 2.0 CORTICAL SCREW DRILL Ø4mm FDA UDI
GAP CORTICAL SCREW ENDMILL FDA UDI
Nail Ø7.2mm X 240mm FDA UDI
Cortical Screw Ø4.0mm X 80mm FDA UDI
Cortical Screw Ø3.0mm X 80mm FDA UDI
Cortical Screw Ø3.0mm X 55mm FDA UDI
GAP 2.0 CANAL REAMER Ø5.6mm FDA UDI
GAP DEPTH GAGE WIRE Ø2.0mm x 360mm - PKG OF 2 FDA UDI
Nail Ø6.4mm X 300mm FDA UDI
Nail Ø4.8mm X 180mm FDA UDI
Nail Ø5.6mm X 200mm FDA UDI
Cortical Screw Ø4.0mm X 24mm FDA UDI
Cortical Screw Ø4.0mm X 38mm FDA UDI
Cortical Peg Ø2.5mm X 60mm FDA UDI
Nail Ø6.4mm X 240mm FDA UDI
GAP 2.0 TARGETING DEVICE FDA UDI
Nail Ø5.6mm X 260mm FDA UDI
GAP 2.0 PROXIMAL CORTICAL SCREW DRILL Ø4mm FDA UDI
Lag Screw Ø5.5mm X 100mm FDA UDI
Nail Ø7.2mm X 160mm FDA UDI
Lag Screw Ø5.5mm X 55mm FDA UDI
Cortical Peg Ø2.5mm X 65mm FDA UDI
GAP 2.0 CONICAL REAMER FDA UDI
Cortical Screw Ø4.0mm X 70mm FDA UDI
Nail Ø7.2mm X 280mm FDA UDI
Cortical Screw Ø4.0mm X 55mm FDA UDI
Nail Ø4.8mm X 280mm FDA UDI
Lag Screw Ø5.5mm X 65mm FDA UDI
Mechanical Screw Ø4.0mm X 24mm FDA UDI
Lag Screw Ø5.5mm X 110mm FDA UDI
Lag Screw Ø5.5mm X 70mm FDA UDI
Cortical Screw Ø3.0mm X 40mm FDA UDI
Nail Ø6.4mm X 280mm FDA UDI
Cortical Screw Ø4.0mm X 28mm FDA UDI
GAP 2.0 CANAL REAMER Ø4.8mm FDA UDI
Lag Screw Ø5.5mm X 50mm FDA UDI
Model / Reference
SLEEVE EUDAMED
GAP-SLS155 EUDAMEDFDA UDI
GAP-DCA064 EUDAMEDFDA UDI
GAP-INE200 EUDAMEDFDA UDI
GAP-IME200 EUDAMEDFDA UDI
GAP-N48-32 EUDAMEDFDA UDI
GAP-N80-30 EUDAMEDFDA UDI
GAP-N80-28 EUDAMEDFDA UDI
GAP-CS4-20 EUDAMEDFDA UDI
GAP-LG080 EUDAMEDFDA UDI
GAP-N56-16 EUDAMEDFDA UDI
GAP-DCA048 EUDAMEDFDA UDI
GAP-N64-18 EUDAMEDFDA UDI
GAP-N56-28 EUDAMEDFDA UDI
GAP-CS3-24 EUDAMEDFDA UDI
GAP-CS4-22 EUDAMEDFDA UDI
GAP-N56-18 EUDAMEDFDA UDI
GAP-LG060 EUDAMEDFDA UDI
GAP-N56-30 EUDAMEDFDA UDI
GAP-DCA272 EUDAMEDFDA UDI
GAP-CS4-75 EUDAMEDFDA UDI
GAP-CP050 EUDAMEDFDA UDI
GAP-KDG360-PKG6 EUDAMEDFDA UDI
GAP-DCS102 EUDAMEDFDA UDI
GAP-IME250 EUDAMEDFDA UDI
GAP-N80-32 EUDAMEDFDA UDI
GAP-KWG016-PKG6 EUDAMEDFDA UDI
GAP-DCS104-L EUDAMEDFDA UDI
GAP-CS2-70 EUDAMEDFDA UDI
GAP-N72-20 EUDAMEDFDA UDI
GAP-CS3-38 EUDAMEDFDA UDI
GAP-DCS102-L EUDAMEDFDA UDI
GAP-DCA056 EUDAMEDFDA UDI
GAP-CS3-50 EUDAMEDFDA UDI
GAP-CS3-32 EUDAMEDFDA UDI
GAP-CS4-40 EUDAMEDFDA UDI
GAP-PLC110 EUDAMEDFDA UDI
GAP-N64-20 EUDAMEDFDA UDI
GAP-N64-16 EUDAMEDFDA UDI
GAP-CS3-22 EUDAMEDFDA UDI
GAP-CS4-30 EUDAMEDFDA UDI
GAP-CS4-34 EUDAMEDFDA UDI
GAP-PLS100 EUDAMEDFDA UDI
GAP-DLG255 EUDAMEDFDA UDI
GAP-CS3-30 EUDAMEDFDA UDI
GAP-PLL100 EUDAMEDFDA UDI
GAP-KWG020 EUDAMEDFDA UDI
GAP-CS3-28 EUDAMEDFDA UDI
GAP-KWG016-PKG2 EUDAMEDFDA UDI
GAP-N72-18 EUDAMEDFDA UDI
GAP-CS3-70 EUDAMEDFDA UDI
GAP-PLC130 EUDAMEDFDA UDI
GAP-LG075 EUDAMEDFDA UDI
GAP-CS4-32 EUDAMEDFDA UDI
GAP-LG085 EUDAMEDFDA UDI
GAP-CS4-26 EUDAMEDFDA UDI
GAP-LG095 EUDAMEDFDA UDI
GAP-MPW200 EUDAMEDFDA UDI
GAP-DMS200 EUDAMEDFDA UDI
GAP-DCS204 EUDAMEDFDA UDI
GAP-DCE100 EUDAMEDFDA UDI
GAP-N72-24 EUDAMEDFDA UDI
GAP-CS4-80 EUDAMEDFDA UDI
GAP-CS3-80 EUDAMEDFDA UDI
GAP-CS3-55 EUDAMEDFDA UDI
GAP-DCA256 EUDAMEDFDA UDI
GAP-KDG360-PKG2 EUDAMEDFDA UDI
GAP-N64-30 EUDAMEDFDA UDI
GAP-N48-18 EUDAMEDFDA UDI
GAP-N56-20 EUDAMEDFDA UDI
GAP-CS4-24 EUDAMEDFDA UDI
GAP-CS4-38 EUDAMEDFDA UDI
GAP-CS2-60 EUDAMEDFDA UDI
GAP-N64-24 EUDAMEDFDA UDI
GAP-TGD200 EUDAMEDFDA UDI
GAP-N56-26 EUDAMEDFDA UDI
GAP-MSD204 EUDAMEDFDA UDI
GAP-LG100 EUDAMEDFDA UDI
GAP-N72-16 EUDAMEDFDA UDI
GAP-LG055 EUDAMEDFDA UDI
GAP-CS2-65 EUDAMEDFDA UDI
GAP-DTP200 EUDAMEDFDA UDI
GAP-CS4-70 EUDAMEDFDA UDI
GAP-N72-28 EUDAMEDFDA UDI
GAP-CS4-55 EUDAMEDFDA UDI
GAP-N48-28 EUDAMEDFDA UDI
GAP-LG065 EUDAMEDFDA UDI
GAP-MS24 EUDAMEDFDA UDI
GAP-LG110 EUDAMEDFDA UDI
GAP-LG070 EUDAMEDFDA UDI
GAP-CS3-40 EUDAMEDFDA UDI
GAP-N64-28 EUDAMEDFDA UDI
GAP-CS4-28 EUDAMEDFDA UDI
GAP-DCA248 EUDAMEDFDA UDI
GAP-LG050 EUDAMEDFDA UDI
CORTICAL SCREW EUDAMED
PLATE EUDAMED
TARGETING DEVICE EUDAMED
NAIL EUDAMED
EMPTY LAG INSTRUMENTS CASE EUDAMED
NAIL CAP EUDAMED
SCREW DRILL EUDAMED
GUIDE WIRE EUDAMED
CANAL REAMER EUDAMED
SCREWDRIVER EUDAMED
EMPTY IMPLANT CASE EUDAMED
LAG WIRE EUDAMED
LAG REAMER EUDAMED
CONICAL REAMER EUDAMED
ENDMILL EUDAMED
Description
GAP CANAL REAMER Ø6.4mm FDA UDI
GAP 2.0 EMPTY INSTRUMENTS CASE FDA UDI
GAP 2.0 EMPTY IMPLANT CASE 1 - NAIL FDA UDI
Nail Ø4.8mm X 320mm FDA UDI
Nail Ø8.0mm X 300mm FDA UDI
Nail Ø8.0mm X 280mm FDA UDI
Cortical Screw Ø4.0mm X 20mm FDA UDI
Lag Screw Ø5.5mm X 80mm FDA UDI
Nail Ø5.6mm X 160mm FDA UDI
GAP CANAL REAMER Ø4.8mm FDA UDI
Nail Ø6.4mm X 180mm FDA UDI
Nail Ø5.6mm X 280mm FDA UDI
Cortical Screw Ø3.0mm X 24mm FDA UDI
Cortical Screw Ø4.0mm X 22mm FDA UDI
Nail Ø5.6mm X 180mm FDA UDI
Lag Screw Ø5.5mm X 60mm FDA UDI
Nail Ø5.6mm X 300mm FDA UDI
GAP 2.0 CANAL REAMER Ø7.2mm FDA UDI
Cortical Screw Ø4.0mm X 75mm FDA UDI
Nail Cap 5.0mm High FDA UDI
GAP DEPTH GAGE WIRE Ø2.0mm x 360mm - PKG OF 6 FDA UDI
GAP CORTICAL SCREW DRILL Ø2.5mm FDA UDI
GAP 2.0 EMPTY IMPANT CASE 2 - COMPONENTS FDA UDI
Nail Ø8.0mm X 320mm FDA UDI
GAP GUIDE WIRE Ø1.6mm - PKG OF 6 FDA UDI
GAP CORTICAL SCREW DRILL-LONG Ø4.0mm FDA UDI
Cortical Peg Ø2.5mm X 70mm FDA UDI
Nail Ø7.2mm X 200mm FDA UDI
Cortical Screw Ø3.0mm X 38mm FDA UDI
GAP CORTICAL SCREW DRILL-LONG Ø2.5mm FDA UDI
GAP CANAL REAMER Ø5.6mm FDA UDI
Cortical Screw Ø3.0mm X 50mm FDA UDI
Cortical Screw Ø3.0mm X 32mm FDA UDI
Cortical Screw Ø4.0mm X 40mm FDA UDI
Coxa Vara Plate Small FDA UDI
Nail Ø6.4mm X 200mm FDA UDI
Nail Ø6.4mm X 160mm FDA UDI
Cortical Screw Ø3.0mm X 22mm FDA UDI
Cortical Screw Ø4.0mm X 30mm FDA UDI
Cortical Screw Ø4.0mm X 34mm FDA UDI
Short Fixation Plate FDA UDI
GAP 2.0 LAG REAMER FDA UDI
GAP LAG SCREW SLEEVE FDA UDI
Cortical Screw Ø3.0mm X 30mm FDA UDI
Long Fixation Plate FDA UDI
GAP GUIDE WIRE Ø2.0mm x 457mm FDA UDI
Cortical Screw Ø3.0mm X 28mm FDA UDI
GAP GUIDE WIRE Ø1.6mm - PKG OF 2 FDA UDI
Nail Ø7.2mm X 180mm FDA UDI
Cortical Screw Ø3.0mm X 70mm FDA UDI
Coxa Vara Plate Large FDA UDI
Lag Screw Ø5.5mm X 75mm FDA UDI
Cortical Screw Ø4.0mm X 32mm FDA UDI
Lag Screw Ø5.5mm X 85mm FDA UDI
Cortical Screw Ø4.0mm X 26mm FDA UDI
Lag Screw Ø5.5mm X 95mm FDA UDI
GAP 2.0 MULTIPURPOSE WRENCH FDA UDI
GAP 2.0 MECHANICAL SCREW DRILL FDA UDI
GAP 2.0 CORTICAL SCREW DRILL Ø4mm FDA UDI
GAP CORTICAL SCREW ENDMILL FDA UDI
Nail Ø7.2mm X 240mm FDA UDI
Cortical Screw Ø4.0mm X 80mm FDA UDI
Cortical Screw Ø3.0mm X 80mm FDA UDI
Cortical Screw Ø3.0mm X 55mm FDA UDI
GAP 2.0 CANAL REAMER Ø5.6mm FDA UDI
GAP DEPTH GAGE WIRE Ø2.0mm x 360mm - PKG OF 2 FDA UDI
Nail Ø6.4mm X 300mm FDA UDI
Nail Ø4.8mm X 180mm FDA UDI
Nail Ø5.6mm X 200mm FDA UDI
Cortical Screw Ø4.0mm X 24mm FDA UDI
Cortical Screw Ø4.0mm X 38mm FDA UDI
Cortical Peg Ø2.5mm X 60mm FDA UDI
Nail Ø6.4mm X 240mm FDA UDI
GAP 2.0 TARGETING DEVICE FDA UDI
Nail Ø5.6mm X 260mm FDA UDI
GAP 2.0 PROXIMAL CORTICAL SCREW DRILL Ø4mm FDA UDI
Lag Screw Ø5.5mm X 100mm FDA UDI
Nail Ø7.2mm X 160mm FDA UDI
Lag Screw Ø5.5mm X 55mm FDA UDI
Cortical Peg Ø2.5mm X 65mm FDA UDI
GAP 2.0 CONICAL REAMER FDA UDI
Cortical Screw Ø4.0mm X 70mm FDA UDI
Nail Ø7.2mm X 280mm FDA UDI
Cortical Screw Ø4.0mm X 55mm FDA UDI
Nail Ø4.8mm X 280mm FDA UDI
Lag Screw Ø5.5mm X 65mm FDA UDI
Mechanical Screw Ø4.0mm X 24mm FDA UDI
Lag Screw Ø5.5mm X 110mm FDA UDI
Lag Screw Ø5.5mm X 70mm FDA UDI
Cortical Screw Ø3.0mm X 40mm FDA UDI
Nail Ø6.4mm X 280mm FDA UDI
Cortical Screw Ø4.0mm X 28mm FDA UDI
GAP 2.0 CANAL REAMER Ø4.8mm FDA UDI
Lag Screw Ø5.5mm X 50mm FDA UDI

Identifiers

Catalog Number
GAP-DCA064 FDA UDI
GAP-INE200 FDA UDI
GAP-IME200 FDA UDI
GAP-N48-32 FDA UDI
GAP-N80-30 FDA UDI
GAP-N80-28 FDA UDI
GAP-CS4-20 FDA UDI
GAP-LG080 FDA UDI
GAP-N56-16 FDA UDI
GAP-DCA048 FDA UDI
GAP-N64-18 FDA UDI
GAP-N56-28 FDA UDI
GAP-CS3-24 FDA UDI
GAP-CS4-22 FDA UDI
GAP-N56-18 FDA UDI
GAP-LG060 FDA UDI
GAP-N56-30 FDA UDI
GAP-DCA272 FDA UDI
GAP-CS4-75 FDA UDI
GAP-CP050 FDA UDI
GAP-KDG360-PKG6 FDA UDI
GAP-DCS102 FDA UDI
GAP-IME250 FDA UDI
GAP-N80-32 FDA UDI
GAP-KWG016-PKG6 FDA UDI
GAP-DCS104-L FDA UDI
GAP-CS2-70 FDA UDI
GAP-N72-20 FDA UDI
GAP-CS3-38 FDA UDI
GAP-DCS102-L FDA UDI
GAP-DCA056 FDA UDI
GAP-CS3-50 FDA UDI
GAP-CS3-32 FDA UDI
GAP-CS4-40 FDA UDI
GAP-PLC110 FDA UDI
GAP-N64-20 FDA UDI
GAP-N64-16 FDA UDI
GAP-CS3-22 FDA UDI
GAP-CS4-30 FDA UDI
GAP-CS4-34 FDA UDI
GAP-PLS100 FDA UDI
GAP-DLG255 FDA UDI
GAP-SLS155 FDA UDI
GAP-CS3-30 FDA UDI
GAP-PLL100 FDA UDI
GAP-KWG020 FDA UDI
GAP-CS3-28 FDA UDI
GAP-KWG016-PKG2 FDA UDI
GAP-N72-18 FDA UDI
GAP-CS3-70 FDA UDI
GAP-PLC130 FDA UDI
GAP-LG075 FDA UDI
GAP-CS4-32 FDA UDI
GAP-LG085 FDA UDI
GAP-CS4-26 FDA UDI
GAP-LG095 FDA UDI
GAP-MPW200 FDA UDI
GAP-DMS200 FDA UDI
GAP-DCS204 FDA UDI
GAP-DCE100 FDA UDI
GAP-N72-24 FDA UDI
GAP-CS4-80 FDA UDI
GAP-CS3-80 FDA UDI
GAP-CS3-55 FDA UDI
GAP-DCA256 FDA UDI
GAP-KDG360-PKG2 FDA UDI
GAP-N64-30 FDA UDI
GAP-N48-18 FDA UDI
GAP-N56-20 FDA UDI
GAP-CS4-24 FDA UDI
GAP-CS4-38 FDA UDI
GAP-CS2-60 FDA UDI
GAP-N64-24 FDA UDI
GAP-TGD200 FDA UDI
GAP-N56-26 FDA UDI
GAP-MSD204 FDA UDI
GAP-LG100 FDA UDI
GAP-N72-16 FDA UDI
GAP-LG055 FDA UDI
GAP-CS2-65 FDA UDI
GAP-DTP200 FDA UDI
GAP-CS4-70 FDA UDI
GAP-N72-28 FDA UDI
GAP-CS4-55 FDA UDI
GAP-N48-28 FDA UDI
GAP-LG065 FDA UDI
GAP-MS24 FDA UDI
GAP-LG110 FDA UDI
GAP-LG070 FDA UDI
GAP-CS3-40 FDA UDI
GAP-N64-28 FDA UDI
GAP-CS4-28 FDA UDI
GAP-DCA248 FDA UDI
GAP-LG050 FDA UDI
Primary DI / UDI-DI
07540194010216 EUDAMEDFDA UDI
07540194009777 EUDAMEDFDA UDI
07540194016898 EUDAMEDFDA UDI
07540194016836 EUDAMEDFDA UDI
07540194000798 EUDAMEDFDA UDI
07540194001085 EUDAMEDFDA UDI
07540194001078 EUDAMEDFDA UDI
07540194001429 EUDAMEDFDA UDI
07540194001160 EUDAMEDFDA UDI
07540194000804 EUDAMEDFDA UDI
07540194009753 EUDAMEDFDA UDI
07540194000903 EUDAMEDFDA UDI
07540194000866 EUDAMEDFDA UDI
07540194001252 EUDAMEDFDA UDI
07540194001436 EUDAMEDFDA UDI
07540194000811 EUDAMEDFDA UDI
07540194001122 EUDAMEDFDA UDI
07540194000873 EUDAMEDFDA UDI
07540194016058 EUDAMEDFDA UDI
07540194001597 EUDAMEDFDA UDI
07540194002198 EUDAMEDFDA UDI
07540194009999 EUDAMEDFDA UDI
07540194009814 EUDAMEDFDA UDI
07540194016867 EUDAMEDFDA UDI
07540194001092 EUDAMEDFDA UDI
07540194010049 EUDAMEDFDA UDI
07540194009869 EUDAMEDFDA UDI
07540194004659 EUDAMEDFDA UDI
07540194001009 EUDAMEDFDA UDI
07540194001320 EUDAMEDFDA UDI
07540194009821 EUDAMEDFDA UDI
07540194009760 EUDAMEDFDA UDI
07540194001351 EUDAMEDFDA UDI
07540194001290 EUDAMEDFDA UDI
07540194001528 EUDAMEDFDA UDI
07540194002136 EUDAMEDFDA UDI
07540194000910 EUDAMEDFDA UDI
07540194000897 EUDAMEDFDA UDI
07540194001245 EUDAMEDFDA UDI
07540194001474 EUDAMEDFDA UDI
07540194001498 EUDAMEDFDA UDI
07540194002228 EUDAMEDFDA UDI
07540194016621 EUDAMEDFDA UDI
07540194001283 EUDAMEDFDA UDI
07540194002211 EUDAMEDFDA UDI
07540194010056 EUDAMEDFDA UDI
07540194001276 EUDAMEDFDA UDI
07540194010032 EUDAMEDFDA UDI
07540194000996 EUDAMEDFDA UDI
07540194001399 EUDAMEDFDA UDI
07540194002150 EUDAMEDFDA UDI
07540194001153 EUDAMEDFDA UDI
07540194001481 EUDAMEDFDA UDI
07540194001177 EUDAMEDFDA UDI
07540194001450 EUDAMEDFDA UDI
07540194001191 EUDAMEDFDA UDI
07540194015785 EUDAMEDFDA UDI
07540194016638 EUDAMEDFDA UDI
07540194016751 EUDAMEDFDA UDI
07540194009807 EUDAMEDFDA UDI
07540194001023 EUDAMEDFDA UDI
07540194001603 EUDAMEDFDA UDI
07540194001412 EUDAMEDFDA UDI
07540194001368 EUDAMEDFDA UDI
07540194016546 EUDAMEDFDA UDI
07540194009982 EUDAMEDFDA UDI
07540194000965 EUDAMEDFDA UDI
07540194000729 EUDAMEDFDA UDI
07540194000828 EUDAMEDFDA UDI
07540194001443 EUDAMEDFDA UDI
07540194001511 EUDAMEDFDA UDI
07540194004345 EUDAMEDFDA UDI
07540194000934 EUDAMEDFDA UDI
07540194016690 EUDAMEDFDA UDI
07540194000859 EUDAMEDFDA UDI
07540194015778 EUDAMEDFDA UDI
07540194001207 EUDAMEDFDA UDI
07540194000989 EUDAMEDFDA UDI
07540194001115 EUDAMEDFDA UDI
07540194004642 EUDAMEDFDA UDI
07540194016683 EUDAMEDFDA UDI
07540194001580 EUDAMEDFDA UDI
07540194001047 EUDAMEDFDA UDI
07540194001559 EUDAMEDFDA UDI
07540194000774 EUDAMEDFDA UDI
07540194001139 EUDAMEDFDA UDI
07540194002167 EUDAMEDFDA UDI
07540194001221 EUDAMEDFDA UDI
07540194001146 EUDAMEDFDA UDI
07540194001337 EUDAMEDFDA UDI
07540194000958 EUDAMEDFDA UDI
07540194001467 EUDAMEDFDA UDI
07540194016744 EUDAMEDFDA UDI
07540194001108 EUDAMEDFDA UDI
Basic UDI-DI
7540194GAP-SLVR7 EUDAMED
7540194GAP-SCWQE EUDAMED
7540194GAP-PLTQL EUDAMED
7540194GAP-TDP5 EUDAMED
7540194GAP-NAILSZQ EUDAMED
7540194GAP-ELINCY8 EUDAMED
7540194GAP-CAPMA EUDAMED
7540194GAP-CSDN8 EUDAMED
7540194GAP-GWP4 EUDAMED
7540194GAP-CRNE EUDAMED
7540194GAP-SDRVSW EUDAMED
7540194GAP-EIMCNY EUDAMED
7540194GAP-DGWNF EUDAMED
7540194GAP-MSDPS EUDAMED
7540194GAP-CORNQ EUDAMED
7540194GAP-EMNA EUDAMED
FDA Product Code
HTO FDA UDI
LXH FDA UDI
HSB FDA UDI
HTW FDA UDI
LYS FDA UDI
EMDN Code
L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
P09120601 CORTICAL SCREWS EUDAMED
P09120599 BONE FIXATION PLATES - OTHER EUDAMED
P09120402 SCREWS EUDAMED
P09120201 INTRAMEDULLARY NAILS EUDAMED
S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
L1508 REAMERS, REUSABLE EUDAMED
L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
GMDN Term
Cannulated surgical drill bit, reusable FDA UDI
Surgical instrument/implant rack FDA UDI
Arthrodesis intramedullary nail, non-distracting FDA UDI
Orthopaedic bone screw (non-sliding) FDA UDI
Bone nail end-cap FDA UDI
Orthopaedic guidewire, single-use FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Surgical drill guide, reusable FDA UDI
Surgical torque wrench, reusable FDA UDI
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Implantable orthopaedic/craniofacial device connection screw FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIb EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
888.4540 FDA UDI
888.3020 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 490 Millimeter FDA UDI
Outer Diameter — 6.6 Millimeter FDA UDI
Lumen/Inner Diameter — 2.15 Millimeter FDA UDI
Length — 150 Millimeter FDA UDI
Outer Diameter — 2.75 Millimeter FDA UDI
Outer Diameter — 1.95 Millimeter FDA UDI
Length — 320 Millimeter FDA UDI
Outer Diameter — 4.8 Millimeter FDA UDI
Length — 300 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI
Length — 280 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI
Outer Diameter — 4 Millimeter FDA UDI
Length — 80 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI
Outer Diameter — 5.6 Millimeter FDA UDI
Length — 160 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI
Lumen/Inner Diameter — 2.2 Millimeter FDA UDI
Outer Diameter — 6.4 Millimeter FDA UDI
Length — 180 Millimeter FDA UDI
Outer Diameter — 3 Millimeter FDA UDI
Length — 24 Millimeter FDA UDI
Length — 22 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI
Outer Diameter — 7.2 Millimeter FDA UDI
Length — 75 Millimeter FDA UDI
Height — 5 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI
Length — 360 Millimeter FDA UDI
Length — 250 Millimeter FDA UDI
Outer Diameter — 2.45 Millimeter FDA UDI
Outer Diameter — 2.35 Millimeter FDA UDI
Length — 457.2 Millimeter FDA UDI
Outer Diameter — 1.6 Millimeter FDA UDI
Outer Diameter — 2.25 Millimeter FDA UDI
Outer Diameter — 2.5 Millimeter FDA UDI
Length — 70 Millimeter FDA UDI
Length — 200 Millimeter FDA UDI
Length — 38 Millimeter FDA UDI
Outer Diameter — 5.8 Millimeter FDA UDI
Length — 50 Millimeter FDA UDI
Length — 32 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI
Length — 34 Millimeter FDA UDI
Length — 28 Millimeter FDA UDI
Length — 85 Millimeter FDA UDI
Length — 26 Millimeter FDA UDI
Length — 95 Millimeter FDA UDI
Length — 220 Millimeter FDA UDI
Outer Diameter — 5.925 Millimeter FDA UDI
Length — 240 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI
Length — 260 Millimeter FDA UDI
Length — 100 Millimeter FDA UDI
Length — 65 Millimeter FDA UDI
Length — 110 Millimeter FDA UDI

The GAP Nail Endo-Exo Medullary System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OrthoPediatrics Canada ULC
EUDAMED SRN
CA-MF-000013010
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (188)

  • EUDAMED fc392db8-4c55-4c68-b339-a0a4fd45b234 61 fields · synced Sep 18, 2026
  • FDA UDI 552cfab3-16ff-4cd2-9b82-772a711531a4 37 fields · synced May 24, 2026
  • FDA UDI e299e9bc-ce03-4cb2-8e35-0f3272b4dd78 36 fields · synced May 24, 2026
  • FDA UDI e90494a5-3c8f-426a-a5cb-000cc7f0f3b1 36 fields · synced May 24, 2026
  • FDA UDI 437fcc53-9a5e-4ed7-9987-f4df07fd138a 37 fields · synced May 24, 2026
  • FDA UDI 028e26fb-ec63-4078-b773-8a4051909209 37 fields · synced May 24, 2026
  • FDA UDI 08b81926-79c0-410f-8d8b-ae9aaf12f385 37 fields · synced May 24, 2026
  • FDA UDI e8ce6d9b-699c-43d4-9e15-c66db20b04c8 37 fields · synced May 24, 2026
  • FDA UDI a958b8d6-4387-42c3-86ed-f7926a17c78c 37 fields · synced May 25, 2026
  • FDA UDI e262fe97-f849-42b5-8509-7da0bcdbfeef 37 fields · synced May 25, 2026
  • FDA UDI 0ccb060d-f2aa-4197-bebc-5327998391f8 37 fields · synced May 26, 2026
  • FDA UDI bfebfddc-37a2-4802-8647-60f7a12e2d8f 37 fields · synced May 27, 2026
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  • FDA UDI 7b4a174e-ea8f-405c-aa9d-a75c48d903f1 37 fields · synced May 27, 2026
  • FDA UDI 892494e4-3207-4940-aba3-b989206930bd 37 fields · synced May 29, 2026
  • FDA UDI 0aee2695-841c-4292-a336-0a6fd37ee5c1 37 fields · synced May 29, 2026
  • FDA UDI ed6258ee-7846-47a8-804b-87ee366d4b99 37 fields · synced May 29, 2026
  • FDA UDI 58984401-a384-44a0-8e80-f8354559c950 36 fields · synced May 29, 2026
  • FDA UDI 90126901-3d45-47a0-a3cb-8e6d24a1bb0a 37 fields · synced May 29, 2026
  • FDA UDI f2e36c25-2013-47f9-a0c2-9b746f1c9b59 37 fields · synced May 29, 2026
  • FDA UDI 63108121-c56a-4cbf-b7a2-24fac3f033d7 37 fields · synced May 29, 2026
  • FDA UDI bacca2f3-d443-4140-9a76-beef477357a8 37 fields · synced May 29, 2026
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  • FDA UDI a5e03542-50a5-4ae8-9252-6fe6fa8afb73 37 fields · synced May 30, 2026
  • EUDAMED d4272d5b-8a57-4f19-9a27-7560fcaacda3 61 fields · synced Jun 20, 2026
  • EUDAMED 3b921fb3-b78a-460c-942c-d7e81aecd2dd 61 fields · synced Jun 20, 2026
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  • EUDAMED 4a22f38f-4500-47c8-85b3-4dd3e12f2c2c 61 fields · synced Jul 9, 2026
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