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Depuy Synthes

by DePuy Ireland UC 51 variants

Ref 1294-56-111Model MBT Revision Wedges

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 22 Oct 2026. What this means

Overview

DePuy Ireland UC's DEPUY SYNTHES device is a Class IIb medical device designed for the treatment of certain types of chronic pain. Made from high-quality materials, it features a unique wedge-shaped design that provides excellent stability and support.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a0043995 Basic UDI-DI 10603295026600UDI-DIDate4 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295026600 UDI-DI Date24 Mar 2015ListedStatusListed 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  • Withdrawn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

Generic Name
Knee arthroplasty wedge
Device Name
Wedges
Model / Ref / Catalog
MBT Revision Wedges, 1294-56-111, 129456111
Primary DI / UDI-DI
10603295026600
Basic UDI-DI
0603295a0043995
FDA Product Code
NJL
EMDN Code
P09098001 Knee prostheses augments
GMDN Term
Knee arthroplasty wedge
Device Class
Class IIb EUDAMED
Class III GUDID
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class III

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No