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Cook G13050

by Cook Incorporated

Ref RABS-100

Cook G13050 (RABS-100) is a device classified as Class IIa in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-00827002CINC23Y9) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D-00827002CINC23Y9), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002CINC23Y9 Basic UDI-DI D-00827002CINC23Y9UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-00827002CINC23Y9 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002CINC23Y9 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI D-00827002CINC23Y9 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-00827002CINC23Y9
  2. Registered EUDAMED B-00827002CINC23Y9

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  • Withdrawn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
Soft-tissue biopsy procedure kit, non-medicated
Model / Ref / Catalog
RABS-100, G13050
Primary DI / UDI-DI
D-00827002CINC23Y9 EUDAMED
00827002130500 GUDID
Basic UDI-DI
B-00827002CINC23Y9
FDA product code
FCG
EMDN code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
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
RABS-100
GUDID
G13050
Primary DI / UDI-DIEUDAMED
D-00827002CINC23Y9
GUDID
00827002130500
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-00827002CINC23Y9; FDA GUDID lists 00827002130500), 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: Soft-tissue biopsy procedure kit, non-medicated

Similar devices in this category

Other devices filed under NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)