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Affixus® Natural Nail® 110035654

by Zimmer, Inc. EUDAMEDGUDID

Active European Union

Ref 110035654

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024BKJC Basic UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024506411 UDI-DIDate21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Affixus® Natural Nail®
Generic Name
Medullary canal orthopaedic reamer, rigid
Device Name
Affixus® Natural Nail® Proximal Humerus Entry Reamer Coring
Model / Ref / Catalog
110035654
Primary DI / UDI-DI
00889024506411
Basic UDI-DI
889024BKJC
Direct Marketing DI
00889024506411
FDA Product Code
HSB
EMDN Code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN Term
Medullary canal orthopaedic reamer, rigid
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3020
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 IIa
GUDID
Class II

Related devices

Category: Medullary canal orthopaedic reamer, rigid

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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