Identity
- Trade Name
- P.F.C. SIGMA FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Augments EUDAMEDP.F.C. SIGMA DISTAL AUGMENT SIZE 3 4mm LEFT FDA UDI
- Model / Reference
- PFC Sigma Augments EUDAMED96-0860 EUDAMEDFDA UDI
- Description
- P.F.C. SIGMA DISTAL AUGMENT SIZE 3 4mm LEFT FDA UDI
Identifiers
- Catalog Number
- 960860 FDA UDI
- Primary DI / UDI-DI
- 10603295234265 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004408N EUDAMED
- FDA Product Code
- NJL FDA UDIJWH FDA UDI
- EMDN Code
- P09098001 KNEE PROSTHESES AUGMENTS EUDAMED
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
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
MR Conditional FDA UDI
Augments by DePuy Ireland UC — Class IIb — 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 | 0603295a004408N | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 4bb2c6a3-bafb-4179-a5e2-d122995d62f2 61 fields · synced Jul 25, 2026
- FDA UDI 0d0d3d90-4f8a-44cd-9731-129d335bd4d6 35 fields · synced May 30, 2026