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Allofit® IT Acetabular Systems 00-8791-001-00

by Zimmer, Inc.

Ref 00-8791-001-00

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024AEQ23 Basic UDI-DI 00889024152441UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024152441 UDI-DI Date10 Nov 2016ListedStatusListed 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  • Withdrawn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
Allofit® IT Acetabular Systems
Generic name
Instrument tray, reusable
Device name
Zimmer Inc Cases and Trays
Model / Ref / Catalog
00-8791-001-00
Primary DI / UDI-DI
00889024152441
Basic UDI-DI
889024AEQ23
Direct marketing DI
00889024152441
FDA product code
FSM
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Instrument tray, 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: Instrument tray, reusable

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (19)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No