Identity
- Trade Name
- Rasp FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- FFX ancillary EUDAMEDAngled rasp with titanium handle FDA UDI
- Model / Reference
- 57.003.00Y EUDAMEDFDA UDI
- Description
- Angled rasp with titanium handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770019503140 EUDAMEDFDA UDI
- Basic UDI-DI
- 377001950357001DE EUDAMED
- Direct Marketing DI
- 03770019503140 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome 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
FFX ancillary by Sc Medica — 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 | 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 de109715-1fa0-4602-ae89-d37c1ff8aa53 61 fields · synced Jun 18, 2026
- FDA UDI 0bbc7d3c-1984-4876-9610-30ee0c1bcea8 33 fields · synced May 22, 2026