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S-Rom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2576-13-020Model S-ROM Hip Distal Stem Trial
Identity
- Trade Name
- S-ROM EUDAMEDFDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Hip Distal Stem Trial EUDAMEDS-ROM OSZ DIST/PRX TRL SIZE 13/20 FDA UDI
- Model / Reference
- S-ROM Hip Distal Stem Trial EUDAMED2576-13-020 EUDAMEDFDA UDI
- Description
- S-ROM OSZ DIST/PRX TRL SIZE 13/20 FDA UDI
Identifiers
- Catalog Number
- 257613020 FDA UDI
- Primary DI / UDI-DI
- 10603295146186 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001388L EUDAMED
- Direct Marketing DI
- 10603295146186 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
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
S-Rom by DePuy Ireland UC — Class IIa — 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 | 0603295a001388L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED a5e6623d-1b80-4cf2-a679-8e40612f4bd9 61 fields · synced Jul 19, 2026
- FDA UDI e72e496c-8fba-4653-a01b-73ff5662acb2 35 fields · synced May 27, 2026