← Back to catalogue
P.F.C. SIGMA High Performance
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9505-02-141Model SPECIALIST 2 Caliper/Gauge
Identity
- Trade Name
- P.F.C. SIGMA High Performance EUDAMEDSIGMA FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Caliper/Gauge EUDAMEDSIGMA HIGH PERFORMANCE BALANCED AP BLOCK STYLUS FDA UDI
- Model / Reference
- SPECIALIST 2 Caliper/Gauge EUDAMED9505-02-141 EUDAMEDFDA UDI
- Description
- SIGMA HIGH PERFORMANCE BALANCED AP BLOCK STYLUS FDA UDI
Identifiers
- Catalog Number
- 950502141 FDA UDI
- Primary DI / UDI-DI
- 10603295228424 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005028K EUDAMED
- Direct Marketing DI
- 10603295228424 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 I EUDAMEDFDA 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
Yes
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
P.F.C. SIGMA High Performance by DePuy Ireland UC — Class I — 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 | 0603295a005028K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED e9555180-f422-4907-b14d-b26161b3b065 61 fields · synced Jul 31, 2026
- FDA UDI 941900f1-ede2-4458-838d-7abbe4404bbf 35 fields · synced May 30, 2026