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Tornier Flex Shoulder System

by Tornier SAS

Ref NCR135, MWF422AModel 08858251006896UV, 08858251028016TZ

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006896UV Basic UDI-DI Date6 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03700434023275 UDI-DI Date8 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  • Withdrawn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 Flex Shoulder System EUDAMEDGUDID
Tornier Flex GUDID
Generic Name
Surgical implant template, reusable
Instrument tray, reusable
Device Name
Tornier SAS Class I Devices - Trays and Tray Accessories - Class I - Non Sterile
Tornier Flex Shoulder System Instrumentation - Trialing Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
08858251006896UV, NCR135, MWF422A, 08858251028016TZ
Primary DI / UDI-DI
03700434023275, 03700386976780
Basic UDI-DI
08858251006896UV, 08858251028016TZ
Direct Marketing DI
03700434023275
03700386976780
FDA Product Code
LXH, FSM
EMDN Code
V0402, L091104
GMDN Term
Surgical implant template, reusable
Instrument tray, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
888.4540, 878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 42 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
FR-MF-000011808

Other devices from Tornier SAS

See all devices from Tornier SAS →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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