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P.f.c. Σ
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 96-1335Model SIGMA Insert TrialRef 86-0277Model S-ROM NOILES ScrewdriverRef 95-4112Model P.F.C SIGMA Tibial Insert RP Trial ProsthesisRef 86-0284Model P.F.C. Instrument Handle C-IRef 86-0274Model PFC Step Wedge Trial
Identity
- Trade Name
- P.F.C. Σ EUDAMEDP.F.C. EUDAMEDFDA UDIP.F.C. SIGMA EUDAMEDP.F.C. SIGMA FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDIKnee tibia prosthesis trial, reusable FDA UDISurgical screwdriver, reusable FDA UDI
- Device Name
- Insert Trial EUDAMEDScrewdriver EUDAMEDTibial Insert RP Trial Prosthesis EUDAMEDInstrument Handle C-I EUDAMEDStep Wedge Trial EUDAMEDP.F.C. MODULAR PLUS TORQUE DRIVER FDA UDIP.F.C. MODULAR PLUS STEP TRIAL SZ 2 15mm FDA UDIP.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 2 20mm 64mm M/L 43mm A/P FDA UDIP.F.C. MODULAR PLUS WEDGE TRIAL SCREWDRIVER FDA UDIP.F.C. SIGMA RP-F TIBIAL INSERT TRIAL SIZE 1 15mm FDA UDI
- Model / Reference
- SIGMA Insert Trial EUDAMED96-1335 EUDAMEDFDA UDI86-0284 EUDAMEDFDA UDI86-0274 EUDAMEDFDA UDI86-0277 EUDAMEDFDA UDI95-4112 EUDAMEDFDA UDIS-ROM NOILES Screwdriver EUDAMEDP.F.C SIGMA Tibial Insert RP Trial Prosthesis EUDAMEDP.F.C. Instrument Handle C-I EUDAMEDPFC Step Wedge Trial EUDAMED
- Description
- P.F.C. MODULAR PLUS TORQUE DRIVER FDA UDIP.F.C. MODULAR PLUS STEP TRIAL SZ 2 15mm FDA UDIP.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 2 20mm 64mm M/L 43mm A/P FDA UDIP.F.C. MODULAR PLUS WEDGE TRIAL SCREWDRIVER FDA UDIP.F.C. SIGMA RP-F TIBIAL INSERT TRIAL SIZE 1 15mm FDA UDI
Identifiers
- Catalog Number
- 860284 FDA UDI860274 FDA UDI961335 FDA UDI860277 FDA UDI954112 FDA UDI
- Primary DI / UDI-DI
- 10603295237082 EUDAMEDFDA UDI10603295215868 EUDAMEDFDA UDI10603295215769 EUDAMEDFDA UDI10603295215790 EUDAMEDFDA UDI10603295230823 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001588S EUDAMED0603295a0004082 EUDAMED0603295a000738H EUDAMED0603295a0004388 EUDAMED0603295a001498R EUDAMED
- Direct Marketing DI
- 10603295237082 EUDAMED10603295215790 EUDAMED10603295230823 EUDAMED10603295215868 EUDAMED10603295215769 EUDAMED
- FDA Product Code
- HWR FDA UDIHWT FDA UDIHXX FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDL26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDIKnee tibia prosthesis trial, reusable FDA UDISurgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI888.4800 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
EUDAMEDEUDAMED
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 (10)
- EUDAMED 2ec16599-ff3b-4177-99b2-c0f8922d45a4 61 fields · synced Aug 2, 2026
- FDA UDI 345cad1f-497a-48d3-be38-1b368b5deb33 35 fields · synced May 30, 2026
- FDA UDI 6ff45fee-3e95-405c-9a0d-5ab185d7e42e 35 fields · synced May 30, 2026
- FDA UDI 56f753d7-0738-407e-a9f1-6ea7cf3a3554 35 fields · synced May 30, 2026
- FDA UDI 99dae246-7165-4d8a-b024-0ea58bc01426 35 fields · synced May 30, 2026
- FDA UDI 3b345bf7-acec-444c-80ff-4bb48491bcdb 35 fields · synced May 30, 2026
- EUDAMED 464d1ef6-c42b-4850-a5d0-f68927348374 61 fields · synced Jul 10, 2026
- EUDAMED 1060382c-bf46-4d0f-a9a4-85c18969ff62 61 fields · synced Jul 12, 2026
- EUDAMED fbfe97a1-50fd-4776-b8f0-4dfbcbf5e234 61 fields · synced Jul 21, 2026
- EUDAMED aad9a5e6-6ce4-4ef9-bab4-1dbe09c7356c 61 fields · synced Aug 2, 2026