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Nitinol Stone Extractor Modified Basket

by Cook Incorporated 2 variants

Ref NGE-017115-MB

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

CE MDR

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/MDR EUDAMED Number0827002CINC050-092_B12G Basic UDI-DI 00827002482951UDI-DIDate3 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002482951 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Nitinol Stone Extractor Modified Basket EUDAMED
NGage GUDID
Generic Name
Biliary/urinary stone retrieval basket, single-use
Model / Ref / Catalog
NGE-017115-MB, G48295
Primary DI / UDI-DI
00827002482951
Basic UDI-DI
0827002CINC050-092_B12G
FDA Product Code
FFL
EMDN Code
U090101 Urinary stone retrieval baskets
GMDN Term
Biliary/urinary stone retrieval basket, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.4680
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NGE-017115-MB
GUDID
G48295
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003180
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • 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
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No