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Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref GAP-CP100Model NAIL CAP
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Device Name
- Nail Cap 10.0mm High FDA UDI
- Model / Reference
- GAP-CP100 EUDAMEDFDA UDINAIL CAP EUDAMED
- Description
- Nail Cap 10.0mm High FDA UDI
Identifiers
- Catalog Number
- GAP-CP100 FDA UDI
- Primary DI / UDI-DI
- 07540194002204 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-CAPMA EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120402 SCREWS EUDAMED
- GMDN Term
- Bone nail end-cap FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDI
Category: Bone nail end-cap
Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone nail end-cap.
- Phantom® Fibula Nail System — Paragon 28 · Class II
- PTN PERITROCHANTERIC NAIL — Biomet Orthopedics, Inc. · Class II
- Micro Screws (INOX) — devemed GmbH · Class IIb
- AJAX Nail — Auxein Medical Private Limited · Class II
- PEDIATRIC LOCKING NAIL SYSTEM — Biomet Orthopedics, Inc. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- EXPert Nail — Synthes · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 13320f13-e238-4670-900c-a39ee2fbb90d 37 fields · synced Jul 12, 2026
- EUDAMED 095b01ae-e3b3-40eb-873a-08fdccc52ceb 61 fields · synced Jun 14, 2026