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S-Rom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2576-20-110Model S-ROM Hip Sleeve Trial
Identity
- Trade Name
- S-ROM EUDAMEDFDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Hip Sleeve Trial EUDAMEDS-ROM ZT TRIAL SLEEVE SIZE 20 D SMALL FDA UDI
- Model / Reference
- S-ROM Hip Sleeve Trial EUDAMED2576-20-110 EUDAMEDFDA UDI
- Description
- S-ROM ZT TRIAL SLEEVE SIZE 20 D SMALL FDA UDI
Identifiers
- Catalog Number
- 257620110 FDA UDI
- Primary DI / UDI-DI
- 10603295146759 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0014087 EUDAMED
- Direct Marketing DI
- 10603295146759 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 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
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
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 | 0603295a0014087 | 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 39c4ea9a-1c2f-4ac5-85ae-8bb585c63102 61 fields · synced Jul 12, 2026
- FDA UDI ced6abc4-8dfd-4a06-b6c6-44ccf5f0534b 35 fields · synced May 30, 2026