Catalog Number

MTA902416

Brand Name

SureStep Foley Tray System Bardex All-Silicone Foley Catheter

Version/Model Number

MTA902416

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

afd91750-4561-46cc-88cb-603f3477b9d6

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

May 23, 2019

Package DI Number

10801741147491

Quantity per Package

10

Contains DI Package

00801741147494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA