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Formed Irrigating Cystotomes 02SP/10

by Sterimedix Limited GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number25056030403945 UDI-DIDate24 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Formed Irrigating Cystotomes
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Model / Ref / Catalog
02SP/10, M3001
Primary DI / UDI-DI
25056030403945
FDA Product Code
MED
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device Class
Class II
Regulation Number
880.6885
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Sterimedix Limited

See all devices from Sterimedix Limited →

Properties

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

Other properties (8)

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