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Lcs Complete Lps P.f.c. Sigma S-Rom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 96-6896Model LCS COMPLETE, LPS, PFC SIGMA, S-ROM Stem Trial
Identity
- Trade Name
- LCS COMPLETE LPS P.F.C. SIGMA S-ROM EUDAMEDN/A FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Stem Trial EUDAMEDUNIVERSAL PRESS-FIT STEM TRIAL 22mm x 150mm FDA UDI
- Model / Reference
- LCS COMPLETE, LPS, PFC SIGMA, S-ROM Stem Trial EUDAMED96-6896 EUDAMEDFDA UDI
- Description
- UNIVERSAL PRESS-FIT STEM TRIAL 22mm x 150mm FDA UDI
Identifiers
- Catalog Number
- 966896 FDA UDI
- Primary DI / UDI-DI
- 10603295496625 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001678T EUDAMED
- Direct Marketing DI
- 10603295496625 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
Lcs Complete Lps P.f.c. Sigma 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 | 0603295a001678T | 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 14d60054-1568-4745-8e3e-846e9998e30f 61 fields · synced Jul 20, 2026
- FDA UDI ed31b707-2cc3-4aac-82d9-01f4e17a5bf4 35 fields · synced May 30, 2026