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Eclipse G25623

by Cook Incorporated

Listed FDA GUDID listing, not in commercial distribution

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 Number00827002256231 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Eclipse
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Model / Ref / Catalog
G25623, ECL-10X8
Primary DI / UDI-DI
00827002256231
FDA Product Code
KNQ
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device Class
Class II
Regulation Number
876.5365
GUDID distribution status
Not in Commercial Distribution

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No