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Rule 95.00.03

by Zimmer, Inc.

Ref 95.00.03

Rule 95.00.03 is a Class I device made by Zimmer, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 889024GJJR) and listed in FDA GUDID since 30 Jun 2020 (UDI-DI 00889024304062), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024GJJR Basic UDI-DI 00889024304062UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024304062 UDI-DI Date30 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024GJJR registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024304062 listed 30 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024304062
  2. Registered EUDAMED 889024GJJR

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  • Withdrawn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
Rule
Generic name
Joint prosthesis implantation kit, reusable
Device name
Ruler
Model / Ref / Catalog
95.00.03
Primary DI / UDI-DI
00889024304062
Basic UDI-DI
889024GJJR
FDA product code
FTY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Joint prosthesis implantation kit, 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
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)