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SureStep Foley Tray System with Bardex Lubricath Foley Catheter

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
SureStep Foley Tray System with Bardex Lubricath Foley Catheter FDA UDI
Generic Name
Indwelling urethral catheterization kit, adult FDA UDI
Device Name
16FR Bardex Lubricath 350ml Meter Single Level Foley Tray with StatLock FDA UDI
Model / Reference
MTA902916 FDA UDI
Description
16FR Bardex Lubricath 350ml Meter Single Level Foley Tray with StatLock FDA UDI

Identifiers

Catalog Number
MTA902916 FDA UDI
Primary DI / UDI-DI
00801741147470 FDA UDI
FDA Product Code
EZC FDA UDI
GMDN Term
Indwelling urethral catheterization kit, adult FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral catheterization kit, adult

SureStep Foley Tray System with Bardex Lubricath Foley Catheter by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral catheterization kit, adult.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
C. R. Bard, Inc.

Sources (1)

  • FDA UDI 0f855a7f-bc4f-4e54-864a-e22235f84605 36 fields · synced May 31, 2026