Catalog Number

143112

Brand Name

Bard® Suprapubic Introducer Foley Catheter Set with Bardex Lubricath

Version/Model Number

143112

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

-

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

37618074-3416-44d7-a3d9-9406cb97a495

Public Version Date

December 04, 2020

Public Version Number

8

DI Record Publish Date

May 29, 2015

Package DI Number

10801741040549

Quantity per Package

6

Contains DI Package

00801741040542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA