Catalog Number

947414

Brand Name

Bard® Foley Tray Bardex® All-Silicone Foley Catheter

Version/Model Number

947414

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

7ef5f9e1-48e9-4370-8e3a-beec4314031c

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

July 23, 2016

Package DI Number

10801741024990

Quantity per Package

10

Contains DI Package

00801741024993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA