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Silicone Foley Catheter FC316S

by Bioptimal International Pte. Ltd.

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 Number08886483507470 UDI-DI Date4 May 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  • Withdrawn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
Silicone Foley Catheter
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog
FC316S, DC-0001-013
Primary DI / UDI-DI
08886483507470
FDA Product Code
EZL
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution

Other devices from Bioptimal International Pte. Ltd.

See all devices from Bioptimal International Pte. Ltd. →

Properties

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

Other properties (8)

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