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SureStep™ Foley Tray System with Bard® All-Silicone Temp Sensing Catheter A119108

by C. R. Bard, Inc.

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 Number00801741100574 UDI-DI Date19 Mar 2016ListedStatusListed 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  • Withdrawn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
SureStep™ Foley Tray System with Bard® All-Silicone Temp Sensing Catheter
Generic Name
Indwelling urethral catheterization kit, adult
Model / Ref / Catalog
A119108
Primary DI / UDI-DI
00801741100574
FDA Product Code
EZL
GMDN Term
Indwelling urethral catheterization kit, adult
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 8 French

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Properties

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

Other properties (7)

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