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Performer G08139

by Cook Incorporated

Ref RCFW-8.0-38-30-RB

Performer G08139 (RCFW-8.0-38-30-RB) is a device classified as Class IIa in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00827002081390) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00827002081390), active as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002081390 Basic UDI-DI 00827002081390UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002081390 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002081390 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00827002081390 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002081390
  2. Registered EUDAMED B-00827002081390

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  • Withdrawn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
Performer® EUDAMED
Performer GUDID
Generic name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
RCFW-8.0-38-30-RB, G08139
Primary DI / UDI-DI
00827002081390
Basic UDI-DI
B-00827002081390
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1340
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
RCFW-8.0-38-30-RB
GUDID
G08139
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: Vascular catheter introduction set, nonimplantable

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

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)