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Omni-Tract® 3530

by Integra Lifesciences Corp.

Ref 3530

Omni-Tract® 3530 is a device classified as Class IIa in the EU and Class I in the US made by Integra Lifesciences Corp., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-10381780269298) and listed in FDA GUDID since 23 Feb 2018 (UDI-DI 10381780269298), active as of 24 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-10381780269298 Basic UDI-DI 10381780269298UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780269298 UDI-DI Date23 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780269298 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 10381780269298 listed 23 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780269298
  2. Registered EUDAMED B-10381780269298

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Omni-Tract®
Generic name
Surgical retraction system, reusable
Device name
Surgical Retractors and Retractor Systems
Model / Ref / Catalog
3530
Primary DI / UDI-DI
10381780269298
Basic UDI-DI
B-10381780269298
FDA product code
FFO, GAD, FGN
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Surgical retraction system, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
876.4730, 878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
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 IIa
GUDID
Class I

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

Related devices

Category: Surgical retraction system, reusable

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)