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31-8106-53-01

by Zimmer, Inc.

Ref 31-8106-053-01

31-8106-53-01 (31-8106-053-01) is a Class I device made by Zimmer, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI B-00889024656130) and listed in FDA GUDID since 11 Aug 2016 (UDI-DI 00889024656130), 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-00889024656130 Basic UDI-DI 00889024656130UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024656130 UDI-DI Date11 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00889024656130 registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024656130 listed 11 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024656130
  2. Registered EUDAMED B-00889024656130

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  • Withdrawn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
31-8106-053-01, 31-8106-53-01
Primary DI / UDI-DI
00889024656130 EUDAMED
00889024273672 GUDID
Basic UDI-DI
B-00889024656130
FDA product code
HTR
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
878.4800
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
31-8106-053-01
GUDID
31-8106-53-01
Primary DI / UDI-DIEUDAMED
00889024656130
GUDID
00889024273672

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00889024656130; FDA GUDID lists 00889024273672), so their flags are not compared.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

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)