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Cook G00661

by Cook Incorporated

Ref TSF-35-50

Cook G00661 (TSF-35-50) is a device classified as Class IIa in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI B-00827002006614) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00827002006614), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002006614 Basic UDI-DI 00827002006614UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002006614 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002006614 registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00827002006614 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002006614
  2. Registered EUDAMED B-00827002006614

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  • Withdrawn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
Cook
Generic name
Peripheral vascular guidewire, manual
Model / Ref / Catalog
TSF-35-50, G00661
Primary DI / UDI-DI
00827002006614
Basic UDI-DI
B-00827002006614
FDA product code
DQX
EMDN code
C04020202 Peripheral vascular therapeutic guidewires, non-hydrophilic
GMDN term
Peripheral vascular guidewire, manual
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TSF-35-50
GUDID
G00661
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Peripheral vascular guidewire, manual

Similar devices in this category

Other devices filed under PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)