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Mountaineer Oct Spinal System

by Medos International SARL EUDAMEDGUDID

Active European Union

Ref 288307200Model MOUNTAINEER INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001455X Basic UDI-DIDate30 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034221533 UDI-DIDate31 Dec 2016ListedStatusListed 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Mountaineer Oct Spinal System EUDAMED
Mountaineer GUDID
Generic Name
Orthopaedic implant driver
Device Name
Mountaineer Drill Guide Inserter Torque Screwdriver Tightener Introducer Compressor
Model / Ref / Catalog
MOUNTAINEER INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE, 288307200
Primary DI / UDI-DI
10705034221533
Basic UDI-DI
0705034a001455X
Direct Marketing DI
10705034221533
FDA Product Code
HWR
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN Term
Orthopaedic implant driver
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

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

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See all devices from Medos International SARL →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No