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5049-11

by Zimmer, Inc.

Ref 00-5049-011-00

5049-11 is a device classified as Class IIa in the EU and Class I in the US made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 889024ASV3P) and listed in FDA GUDID since 22 Jul 2016 (UDI-DI 00889024376564), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024ASV3P Basic UDI-DI 00889024376564UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024376564 UDI-DI Date22 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024ASV3P registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00889024376564 listed 22 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024376564
  2. Registered EUDAMED 889024ASV3P

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  • Withdrawn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
Disposable Mixing Bowl And Spatula
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Bone Cement Disposable Mixing Bowls with Spatula
Model / reference
00-5049-011-00 EUDAMED
5049-11 GUDID
Primary DI / UDI-DI
00889024376564
Basic UDI-DI
889024ASV3P
FDA product code
JDZ
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4210
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-5049-011-00
GUDID
5049-11
Device classEUDAMED
Class IIa
GUDID
Class I
Contains latexEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 00889024376564: EUDAMED states No, FDA GUDID states Yes.

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 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains latex NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)