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Idys™- TLIF 31761000

by Clariance, Inc.

Ref 31761000

Idys™- TLIF 31761000 is a device classified as Class I in the EU and Class II in the US made by Clariance, Inc., registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 0370078069965PGNH4) and listed in FDA GUDID since 22 May 2018 (UDI-DI 03700780628223), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0370078069965PGNH4 Basic UDI-DI 03700780628223UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780628223 UDI-DI Date22 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0370078069965PGNH4 registered 15 Sep 2026 Active
  • FDA GUDID UDI-DI 03700780628223 listed 22 May 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700780628223
  2. Registered EUDAMED 0370078069965PGNH4

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  • Withdrawn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
Bone Graft Impactor EUDAMED
Idys™- TLIF GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Spinal Instrumentation
Model / Ref / Catalog
31761000
Primary DI / UDI-DI
03700780628223
Basic UDI-DI
0370078069965PGNH4
FDA product code
MAX
EMDN code
P090799 Spinal prostheses and stabilisation systems - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Standard device
EU market of registration
France
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 surgical procedure kit, non-medicated, reusable

Similar devices in this category

Other devices filed under SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER.

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)