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Na MWH104

by Tornier, Inc.

Ref MWH104Model 08858251006583U5

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006583U5 Basic UDI-DI 00846832091966UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832091966 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Tornier Approach
Generic Name
Hand-held surgical retractor, reusable
Device Name
Tornier Approach Instrument System - Distraction/Retraction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWH104, 08858251006583U5
Primary DI / UDI-DI
00846832091966
Basic UDI-DI
08858251006583U5
Direct Marketing DI
00846832091966
FDA Product Code
GAD
EMDN Code
L0915 Spreaders and retractors for orthopaedic surgery, reusable
GMDN Term
Hand-held surgical retractor, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Hand-held surgical retractor, reusable

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No