S-Rom
by DePuy Ireland UC Ireland EUDAMEDGUDID
Ref 53-2999Model TISSUE SPARING SOLUTIONS Inserter/Extractor
Product code HWBEMDN L091101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0603295a004789F | Date23 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10603295171683 | Date24 Sep 2018 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthopaedic implant/instrument dismantling device
- Device Name
- Inserter/Extractor
- Model / Ref / Catalog
- TISSUE SPARING SOLUTIONS Inserter/Extractor, 53-2999, 532999
- Primary DI / UDI-DI
- 10603295171683
- Basic UDI-DI
- 0603295a004789F
- Direct Marketing DI
- 10603295171683
- FDA Product Code
- HWB
- EMDN Code
- L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
- GMDN Term
- Orthopaedic implant/instrument dismantling device
- Device Class
- Class I
- Regulation Number
- 888.4540
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED e8aed1fd-ac76-4e50-a1c9-a8ef39e5abdc
- FDA UDI ad90f9dc-4c2d-452c-9bdf-2aab390f40cd