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TriForce G56413

by Cook Incorporated

Ref KCXS-5.0-35-65-RB-0/DAV-HC

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002564138 Basic UDI-DI 00827002564138UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002564138 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
TriForce™ EUDAMED
TriForce GUDID
Generic Name
Angiographic catheter, single-use
Model / Ref / Catalog
KCXS-5.0-35-65-RB-0/DAV-HC, G56413
Primary DI / UDI-DI
00827002564138
Basic UDI-DI
B-00827002564138
FDA Product Code
KRA
EMDN Code
C0104020101 Panoramic and selective peripheral diagnostic angiography catheters and microcatheters
GMDN Term
Angiographic catheter, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1210
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KCXS-5.0-35-65-RB-0/DAV-HC
GUDID
G56413
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Angiographic catheter, single-use

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No