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All Silicone Foley Catheter F01B062404

by Well Lead Medical Co., Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06936881196515 UDI-DI Date17 May 2024ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
All Silicone Foley Catheter
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Reference
F01B062404
Primary DI / UDI-DI
06936881196515
510(k) Number
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

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K082815)

Show all (12)

Other devices from Well Lead Medical Co., Ltd

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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