Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Implantable orthopaedic/craniofacial device connection screw FDA UDI
- Device Name
- Mechanical Screw Ø4.0mm X 34mm FDA UDI
- Model / Reference
- GAP-MS34 EUDAMEDFDA UDICORTICAL SCREW EUDAMED
- Description
- Mechanical Screw Ø4.0mm X 34mm FDA UDI
Identifiers
- Catalog Number
- GAP-MS34 FDA UDI
- Primary DI / UDI-DI
- 07540194002174 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-SCWQE EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120402 SCREWS EUDAMED
- GMDN Term
- Implantable orthopaedic/craniofacial device connection screw 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 34 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Implantable orthopaedic/craniofacial device connection screw
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 Implantable orthopaedic/craniofacial device connection screw.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 0f74aa17-6672-491e-9ba6-7ea2f1f71f2f 37 fields · synced Jun 11, 2026
- EUDAMED 3925e6e7-2cd1-422c-b443-ec9b353b8d6e 61 fields · synced Jun 11, 2026