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Identity™ Shoulder System SBHT0010

by Zimmer, Inc.

Ref SBHT0010

Identity™ Shoulder System SBHT0010 is a Class I device made by Zimmer, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 889024BQM34) and listed in FDA GUDID since 22 Sep 2022 (UDI-DI 00889024624863), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024BQM34 Basic UDI-DI 00889024624863UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024624863 UDI-DI Date22 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024BQM34 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024624863 listed 22 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024624863
  2. Registered EUDAMED 889024BQM34

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  • Withdrawn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
Identity™ Shoulder System
Generic name
Medullary canal orthopaedic reamer, rigid
Device name
IDENTITY Hum Tray Onlay Reamers
Model / Ref / Catalog
SBHT0010
Primary DI / UDI-DI
00889024624863
Basic UDI-DI
889024BQM34
FDA product code
HTO
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Medullary canal orthopaedic reamer, rigid
Device class
Class I
Regulation number
888.4540
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: Medullary canal orthopaedic reamer, rigid

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, 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, all answered No)