Identity
- Trade Name
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- RASP HOLDER EUDAMEDRASP HANDLE FDA UDI
- Model / Reference
- 910-0205 EUDAMEDFDA UDI
- Description
- RASP HANDLE FDA UDI
Identifiers
- Catalog Number
- 910-0205 FDA UDI
- Primary DI / UDI-DI
- 03701037312353 EUDAMEDFDA UDI
- Basic UDI-DI
- 37010373ACCESSORYS9 EUDAMED
- Direct Marketing DI
- 03701037312353 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, 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
Rasp Holder by FX Shoulder Solutions — 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 | 37010373ACCESSORYS9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FX Shoulder Solutions
- EUDAMED SRN
- FR-MF-000000465
Sources (2)
- EUDAMED 26c82338-6031-4b48-8ea1-b1adee774a08 61 fields · synced Jun 18, 2026
- FDA UDI f287cd1e-15ea-4968-b172-2372d55fda41 35 fields · synced May 30, 2026