← Back to catalogue

SureStep™ Foley Tray System Bardex® IC Complete Care®

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
SureStep™ Foley Tray System Bardex® IC Complete Care® FDA UDI
Generic Name
Indwelling urethral catheterization kit, adult FDA UDI
Device Name
SureStep® Foley Tray System Bardex® IC Complete Care® Infection Control Coude Foley Catheter Tray 350 ml Urine Meter FDA UDI
Model / Reference
A304718A FDA UDI
Description
SureStep® Foley Tray System Bardex® IC Complete Care® Infection Control Coude Foley Catheter Tray 350 ml Urine Meter FDA UDI

Identifiers

Catalog Number
A304718A FDA UDI
Primary DI / UDI-DI
00801741100376 FDA UDI
FDA Product Code
MJC 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

Dimensions & Sizes

Size
Catheter Gauge — 18 French FDA UDI

Category: Indwelling urethral catheterization kit, adult

SureStep™ Foley Tray System Bardex® IC Complete Care® 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
C. R. Bard, Inc.

Sources (1)

  • FDA UDI d45fa172-f866-482c-b5e0-1a45fd94ea16 36 fields · synced May 31, 2026