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Self Centering
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2038-16-000Model SELF CENTERING Trial Liner Spacers
Identity
- Trade Name
- SELF CENTERING EUDAMEDDEPUY FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Trial Liner Spacers EUDAMEDDEPUY TRIAL TAPER SPACER -3 12/14 TAPER FDA UDI
- Model / Reference
- SELF CENTERING Trial Liner Spacers EUDAMED2038-16-000 EUDAMEDFDA UDI
- Description
- DEPUY TRIAL TAPER SPACER -3 12/14 TAPER FDA UDI
Identifiers
- Catalog Number
- 203816000 FDA UDI
- Primary DI / UDI-DI
- 10603295084327 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001298K EUDAMED
- Direct Marketing DI
- 10603295084327 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, 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
Self Centering 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 | 0603295a001298K | 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 073b7418-fa6b-4f42-9580-6340e109d7de 61 fields · synced Jun 18, 2026
- FDA UDI 0a84229a-467e-4fa6-9c79-03a31ec5fcf6 35 fields · synced May 29, 2026