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SureStep Foley Tray System Bard Vertus Foley Catheter Tray

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
SureStep Foley Tray System Bard Vertus Foley Catheter Tray FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
SureStep Foley Tray System Bard Vertus Foley Catheter Tray FDA UDI
Model / Reference
AF42216 FDA UDI
Description
SureStep Foley Tray System Bard Vertus Foley Catheter Tray FDA UDI

Identifiers

Catalog Number
AF42216 FDA UDI
Primary DI / UDI-DI
00801741099090 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial 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

No

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

Dimensions & Sizes

Size
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

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

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

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 f184e6b6-e21d-492a-9fcf-ac5dce443203 36 fields · synced Jun 8, 2026