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31-8106-43

by Zimmer, Inc.

Ref 31-8106-043-00

31-8106-43 (31-8106-043-00) is a device classified as Class IIa in the EU and Class I in the US made by Zimmer, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI B-00889024273597) and listed in FDA GUDID since 10 Aug 2016 (UDI-DI 00889024273597), 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-00889024273597 Basic UDI-DI 00889024273597UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024273597 UDI-DI Date10 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00889024273597 registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024273597 listed 10 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024273597
  2. Registered EUDAMED B-00889024273597

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  • Withdrawn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
Coonrad/Morrey Total Elbow
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
31-8106-043-00, 31-8106-43
Primary DI / UDI-DI
00889024273597
Basic UDI-DI
B-00889024273597
FDA product code
KIH
EMDN code
P0901040201 Shoulder prostheses non modular stems
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4200
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
31-8106-043-00
GUDID
31-8106-43
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES NON MODULAR STEMS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)