← Back to catalogue
S-Rom
EUDAMEDFDA UDIClass I (EU MDR)
Ref 53-4522Model TISSUE SPARING SOLUTIONS Inserter/Extractor
Identity
- Trade Name
- S-ROM EUDAMEDFDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Inserter/Extractor EUDAMEDS-ROM BLADE SLEEVE EXTRACTOR SIZE 22/24 FDA UDI
- Model / Reference
- TISSUE SPARING SOLUTIONS Inserter/Extractor EUDAMED53-4522 EUDAMEDFDA UDI
- Description
- S-ROM BLADE SLEEVE EXTRACTOR SIZE 22/24 FDA UDI
Identifiers
- Catalog Number
- 534522 FDA UDI
- Primary DI / UDI-DI
- 10603295172017 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004789F EUDAMED
- Direct Marketing DI
- 10603295172017 EUDAMED
- FDA Product Code
- HWB FDA UDI
- EMDN Code
- L091101 ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
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
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 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 | 0603295a004789F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED f4151947-9d31-40a5-9c90-1db7e74472e5 61 fields · synced Jul 10, 2026
- FDA UDI f48d989c-5180-40c9-8927-7b65b4ec91b0 35 fields · synced May 30, 2026