Identity
- Trade Name
- P.F.C. Σ EUDAMEDP.F.C. SIGMA FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- Insert Trial EUDAMEDP.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 2 17.5mm 64mm M/L 43mm A/P FDA UDI
- Model / Reference
- SIGMA Insert Trial EUDAMED96-1334 EUDAMEDFDA UDI
- Description
- P.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 2 17.5mm 64mm M/L 43mm A/P FDA UDI
Identifiers
- Catalog Number
- 961334 FDA UDI
- Primary DI / UDI-DI
- 10603295237068 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001588S EUDAMED
- Direct Marketing DI
- 10603295237068 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Knee tibia prosthesis trial, 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
P.f.c. Σ 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 | 0603295a001588S | 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 8a79404a-c592-4fa1-a189-026b10f4ed5f 61 fields · synced Jun 18, 2026
- FDA UDI 6171b68b-eefc-4166-a453-401f223c4786 35 fields · synced May 30, 2026