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by Medos International SARL EUDAMEDGUDID

Active European Union

Ref 3010-21-109Model Navigation Enabled Instruments for Disc Preparation and Interbody

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002786K Basic UDI-DIDate8 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034647609 UDI-DIDate9 Jul 2026ListedStatusListed 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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Orthopaedic chisel
Device Name
Navigation Enabled Curette Disc Opener Osteotome Shaver Spreader CONDUIT Inserter Trial
Model / Ref / Catalog
Navigation Enabled Instruments for Disc Preparation and Interbody, 3010-21-109, 301021109
Primary DI / UDI-DI
10705034647609
Basic UDI-DI
0705034a002786K
Direct Marketing DI
10705034647609
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN Term
Orthopaedic chisel
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
Belgium
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

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Manufacturing Date: No