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SIGMA High Performance

by DePuy Ireland UC 5 variants

Ref 9505-02-056, 96-1778, 96-3365, 86-6568, 9505-02-143, 9505-01-243, 96-1689, 96-1691, 96-3351, 97-2340, 9505-02-048, 96-3125, 96-1673, 96-1690, 97-2372, 96-3332, 96-3117Model 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a002188K Basic UDI-DI Date30 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295227724 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  • Withdrawn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
SIGMA High Performance
Sigma
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Orthopaedic broach
Instrument tray, reusable
Surgical torque wrench, reusable
Knee tibia prosthesis trial, reusable
Fluted surgical drill bit, reusable
Surgical implant template, reusable
Device Name
Drill
Femoral Adapter Trial
Trial - Tibial Insert
Tibial Stem Trial
IM Rod
Femoral/Tibial Stylus, Knee
Orthopaedic Punch
Wrench
Model / Ref / Catalog
9505-02-056, 9505-02-143, 9505-02-048, 96-1691, 96-1673, 96-1689, 97-2340, 96-3332, 9505-01-243, 96-3117, 96-3125, 96-3365, 96-1690, 86-6568, 96-3351, 97-2372, 96-1778, TruMatch Instrument Case/Tray, 950502143, 950502048, 961691, 961673, 961689, 972340, 963332, 950501243, 963117, 963125, 963365, 950502056, 961690, 866568, 963351, 972372, 961778
Primary DI / UDI-DI
10603295227724, 10603295228448, 10603295227649, 10603295239871, 10603295239789, 10603295239857, 10603295251033, 10603295246220, 10603295225485, 10603295245643, 10603295245698, 10603295246497, 10603295239864, 10603295217251, 10603295246374, 10603295251231, 10603295240129
Basic UDI-DI
0603295a002188K, 0603295a001598U, 0603295a001648M, 0603295a001518C, 0603295a005148S, 0603295a0045797, 0603295a000107R, 0603295a001588S, 0603295a002368M, 0603295a0004286
Direct Marketing DI
10603295227724
10603295240129
10603295246497
10603295217251
10603295228448
10603295225485
10603295239857
10603295239871
10603295246374
10603295251033
10603295227649
10603295245698
10603295239789
10603295239864
10603295251231
10603295246220
10603295245643
FDA Product Code
HWT, LRY, FSM, HXC, HWE
EMDN Code
L091102, L091199, L0999, L090999
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Orthopaedic broach
Instrument tray, reusable
Surgical torque wrench, reusable
Knee tibia prosthesis trial, reusable
Fluted surgical drill bit, reusable
Surgical implant template, reusable
Device Class
Class IIa EUDAMED
Class I EUDAMEDGUDID
Regulation Number
888.4800, 878.4800, 888.4540, 878.4820
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

Related devices

Category: Acetabular orthopaedic reamer

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Properties

  • Reusable NoEUDAMEDYesEUDAMED
  • CMR Substance YesEUDAMEDNoEUDAMED
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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