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7712-64

by Zimmer, Inc.

Ref 00-7712-064-00

7712-64 (00-7712-064-00) is a Class I device made by Zimmer, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI B-00889024654181) and listed in FDA GUDID since 20 Jul 2016 (UDI-DI 00889024654181), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024654181 Basic UDI-DI 00889024654181UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024654181 UDI-DI Date20 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00889024654181 registered 1 Nov 2026 Active
  • FDA GUDID UDI-DI 00889024654181 listed 20 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024654181
  2. Registered EUDAMED B-00889024654181

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Stem Driver
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
M/L Taper Stem Inserters
Model / Ref / Catalog
00-7712-064-00, 7712-64
Primary DI / UDI-DI
00889024654181 EUDAMED
00889024132429 GUDID
Basic UDI-DI
B-00889024654181
FDA product code
HWR
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-7712-064-00
GUDID
7712-64
Primary DI / UDI-DIEUDAMED
00889024654181
GUDID
00889024132429

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00889024654181; FDA GUDID lists 00889024132429), so their flags are not compared.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)