Identity
- Trade Name
- Graft holder FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- FFX ancillary EUDAMEDGraft holder - 5 mm height FDA UDI
- Model / Reference
- 57.004.00 EUDAMEDFDA UDI
- Description
- Graft holder - 5 mm height FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760418040216 EUDAMEDFDA UDI
- Basic UDI-DI
- 377001950357001DE EUDAMED
- Direct Marketing DI
- 03760418040216 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Internal spinal fixation procedure kit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
Category: Wire holding/twisting forceps
FFX ancillary by Sc Medica — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 377001950357001DE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sc Medica
- EUDAMED SRN
- FR-MF-000002722
Sources (2)
- EUDAMED cbf31b53-1e01-4d3c-8b56-01960f22d1c0 61 fields · synced Jul 21, 2026
- FDA UDI 008faf90-401c-4f80-bfc6-73fa2e75e50f 33 fields · synced May 29, 2026