Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- GAP CONICAL REAMER FOR Ø 4.8, 5.6, 6.4 mm NAILS FDA UDI
- Model / Reference
- GAP-DTP101 EUDAMEDFDA UDICONICAL REAMER EUDAMED
- Description
- GAP CONICAL REAMER FOR Ø 4.8, 5.6, 6.4 mm NAILS FDA UDI
Identifiers
- Catalog Number
- GAP-DTP101 FDA UDI
- Primary DI / UDI-DI
- 07540194009937 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-CORNQ EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L1508 REAMERS, REUSABLE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 9.3 Millimeter FDA UDILumen/Inner Diameter — 2.2 Millimeter FDA UDI
Category: Cannulated surgical drill bit, reusable
Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, reusable.
- Thunderbolt — RESPONSIVE ORTHOPEDICS LLC · Class I
- 4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
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- BIXCUT — Stryker Corp. · Class I
- Tornier Perform — TORNIER, INC. · Class I
- EVOL®SI Joint Fusion System — CUTTING EDGE SPINE
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 2dded0d4-c778-41d2-b81d-e0341c5303b7 37 fields · synced Jun 19, 2026
- EUDAMED a4abb455-59c6-424d-901c-3aab8541e1f9 61 fields · synced Jun 19, 2026