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P.F.C. Sigma

by DePuy Ireland UC 31 variants

Ref 95-4153, 2178-30-146, 2178-30-128, 95-4127, 95-4113, 2178-30-145Model ATTUNE, PFC-SIGMA Trial for Tibial Insert Prosthesis, RP, TruMatch Instrument Case/Tray

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a000738H Basic UDI-DI Date18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295231073 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
P.F.C. Sigma EUDAMEDGUDID
Sigma Rp EUDAMED
Sigma GUDID
Generic Name
Device sterilization/disinfection container, reusable
Knee tibia prosthesis trial, reusable
Instrument tray, reusable
Device Name
Trial for Tibial Insert Prosthesis, RP
Instrument Case/Tray
Model / Ref / Catalog
ATTUNE, PFC-SIGMA Trial for Tibial Insert Prosthesis, RP, 95-4153, 2178-30-146, 95-4127, 2178-30-128, 95-4113, 2178-30-145, TruMatch Instrument Case/Tray, 217830146, 954127, 217830128, 954113, 217830145, 954153
Primary DI / UDI-DI
10603295231073, 10603295094227, 10603295230946, 10603295094043, 10603295230830, 10603295094210
Basic UDI-DI
0603295a000738H, 0603295a0004184, 0603295a000107R
Direct Marketing DI
10603295231073
10603295094227
10603295094043
10603295230946
10603295230830
10603295094210
FDA Product Code
FSM, HWT
EMDN Code
L091199, L0999
GMDN Term
Device sterilization/disinfection container, reusable
Knee tibia prosthesis trial, reusable
Instrument tray, reusable
Device Class
Class IIa EUDAMED
Class I EUDAMEDGUDID
Regulation Number
878.4800, 888.4800
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
Class I
GUDID
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No