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ClearTract 211810SPT

by Silq Technologies, Corp.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850041415161 UDI-DI Date21 May 2024ListedStatusListed 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  • Withdrawn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
ClearTract
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Reference
211810SPT
Primary DI / UDI-DI
00850041415161
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
MRI Safety
MR Safe

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Other devices from Silq Technologies, Corp.

Properties

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

Other properties (9)

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