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3318

by Zimmer, Inc.

Ref 00-3318-000-00

3318 is a Class I device made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00889024066397) and listed in FDA GUDID since 27 Jul 2016 (UDI-DI 00889024066397), 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-00889024066397 Basic UDI-DI 00889024066397UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024066397 UDI-DI Date27 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00889024066397 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00889024066397 listed 27 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024066397
  2. Registered EUDAMED B-00889024066397

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  • Withdrawn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
Taper Jaw Rongeur
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference
00-3318-000-00 EUDAMED
3318 GUDID
Primary DI / UDI-DI
00889024066397
Basic UDI-DI
B-00889024066397
FDA product code
HTX
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 · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-3318-000-00
GUDID
3318

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)