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Latitude 9030395

by Tornier, Inc.

Ref 9030395Model 08858251007152TD

Latitude 9030395 is a device classified as Class I in the EU and Class II in the US made by Tornier, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 08858251007152TD) and listed in FDA GUDID since 8 May 2019 (UDI-DI 00846832072927), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251007152TD Basic UDI-DI 00846832072927UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832072927 UDI-DI Date8 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007152TD registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00846832072927 listed 8 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832072927
  2. Registered EUDAMED 08858251007152TD

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  • Withdrawn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
Latitude® EV EUDAMED
Latitude GUDID
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Device name
Latitude Instruments - Extraction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
9030395, 08858251007152TD
Primary DI / UDI-DI
00846832072927
Basic UDI-DI
08858251007152TD
Direct marketing DI
00846832072927
FDA product code
JDC, JDB
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3150, 888.3160
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)