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Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref GAP-CS4-38Model CORTICAL SCREW
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Cortical Screw Ø4.0mm X 38mm FDA UDI
- Model / Reference
- GAP-CS4-38 EUDAMEDFDA UDICORTICAL SCREW EUDAMED
- Description
- Cortical Screw Ø4.0mm X 38mm FDA UDI
Identifiers
- Catalog Number
- GAP-CS4-38 FDA UDI
- Primary DI / UDI-DI
- 07540194001511 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-SCWQE EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
- Length — 38 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 3f57197d-51fe-4f03-885c-c6efe6aeaae3 37 fields · synced Oct 7, 2026
- EUDAMED 5d086c4b-68e8-479d-979f-2f409de69c72 61 fields · synced Jun 20, 2026