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Anatomical Shoulder™ Bigliani/Flatow® 01.04255.002

by Zimmer, Inc.

Ref 01.04255.002

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024PULA Basic UDI-DI 00889024287907UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024287907 UDI-DI Date20 Feb 2020ListedStatusListed 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  • Withdrawn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
Anatomical Shoulder™ Bigliani/Flatow®
Generic Name
Joint prosthesis implantation kit, reusable
Device Name
Anatomical Shoulder™ Bigliani/Flatow® Tray
Model / Ref / Catalog
01.04255.002
Primary DI / UDI-DI
00889024287907
Basic UDI-DI
889024PULA
FDA Product Code
HSD, KWT, KWS
EMDN Code
P09010304 Monoblock glenoids
GMDN Term
Joint prosthesis implantation kit, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3690, 888.3650, 888.3660
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Joint prosthesis implantation kit, reusable

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Expiration Date: No