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OpTUS Ultra Pleural G60666

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00827002606661 UDI-DI Date22 Oct 2026ListedStatusListed 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  • Withdrawn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
OpTUS Ultra Pleural
Generic Name
Pleural/peritoneal drainage catheterization kit, medicated
Model / Ref / Catalog
G60666, OPTUS-TRAY-10-20-PIGTAIL
Primary DI / UDI-DI
00827002606661
FDA Product Code
JOL
GMDN Term
Pleural/peritoneal drainage catheterization kit, medicated
Device Class
Class II
Regulation Number
880.6740
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (5)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • HCT/P: No
  • Serial Number: No