Catalog Number

A902414

Brand Name

SureStep™ Foley Tray System Bardex® All- Silicone Foley Catheter Tray

Version/Model Number

A902414

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

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

5da7383d-5d06-407a-8a26-a68ea0474980

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

December 06, 2015

Package DI Number

10801741074032

Quantity per Package

10

Contains DI Package

00801741074035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA