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Cook G14515

by Cook Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00827002145153 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cook
Generic Name
Ureteropelvic balloon catheter
Model / Ref / Catalog
G14515, 028003
Primary DI / UDI-DI
00827002145153
FDA Product Code
EZN
GMDN Term
Ureteropelvic balloon catheter
Device Class
Class II
Regulation Number
876.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ureteropelvic balloon catheter

Similar devices

Also classified as Ureteropelvic balloon catheter.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

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

Other properties (7)

  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No