Identity
- Trade Name
- P.F.C. SIGMA FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Device Name
- P.F.C. SIGMA PATELLA OVAL DOME 1-PEG 41mm CEMENTED FDA UDI
- Model / Reference
- 96-0133 FDA UDI
- Description
- P.F.C. SIGMA PATELLA OVAL DOME 1-PEG 41mm CEMENTED FDA UDI
Identifiers
- Catalog Number
- 960133 FDA UDI
- Primary DI / UDI-DI
- 10603295232810 FDA UDI
- FDA Product Code
- NJL FDA UDI
- GMDN Term
- Polyethylene patella prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
P.f.c. Sigma by Depuy Orthopaedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI bd547a5b-d40d-458e-8c9b-06ad55053b61 36 fields · synced Jun 8, 2026