Catalog Number

A947618

Brand Name

SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter

Version/Model Number

A947618

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EZC

Product Code Name

CATHETER, COUDE

Public Device Record Key

71659af7-de5a-4739-96da-61ee5bf0595a

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

July 12, 2016

Package DI Number

10801741100786

Quantity per Package

10

Contains DI Package

00801741100789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA