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The GAP Nail Endo-Exo Medullary System
EUDAMEDFDA UDIClass I (EU MDR)
Ref GAP-LCK080Model POSITION LOCK ASSEMBLY
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Device Name
- GAP POSITION LOCK ASSEMBLY FDA UDI
- Model / Reference
- POSITION LOCK ASSEMBLY EUDAMEDGAP-LCK080 EUDAMEDFDA UDI
- Description
- GAP POSITION LOCK ASSEMBLY FDA UDI
Identifiers
- Catalog Number
- GAP-LCK080 FDA UDI
- Primary DI / UDI-DI
- 07540194010087 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-PLAPE EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument/implant depth limiter, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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 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
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194GAP-PLAPE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 12ddbc5c-5c5e-49e3-951c-aa1e75f2ecf1 61 fields · synced Jul 10, 2026
- FDA UDI 8ee91b1c-f040-4d84-9486-901a327ac678 36 fields · synced May 30, 2026