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Newton G00715

by Cook Incorporated

Ref TSFNB-35-145

Newton G00715 (TSFNB-35-145) is a device classified as Class IIa in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-00827002CINC13Y6) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D-00827002CINC13Y6), 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-00827002CINC13Y6 Basic UDI-DI D-00827002CINC13Y6UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-00827002CINC13Y6 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002CINC13Y6 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI D-00827002CINC13Y6 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-00827002CINC13Y6
  2. Registered EUDAMED B-00827002CINC13Y6

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  • Withdrawn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
Newton
Generic name
Peripheral vascular guidewire, manual
Model / Ref / Catalog
TSFNB-35-145, G00715
Primary DI / UDI-DI
D-00827002CINC13Y6 EUDAMED
00827002007154 GUDID
Basic UDI-DI
B-00827002CINC13Y6
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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TSFNB-35-145
GUDID
G00715
Primary DI / UDI-DIEUDAMED
D-00827002CINC13Y6
GUDID
00827002007154
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-00827002CINC13Y6; FDA GUDID lists 00827002007154), so their flags are not compared. 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)