Catalog Number

771215

Brand Name

Bard® Urethral Catheterization Tray with Red Rubber Catheter

Version/Model Number

771215

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

EYB

Product Code Name

CATHETER, URETERAL, GASTRO-UROLOGY

Public Device Record Key

029a755e-4929-480e-8dd9-f6ee2af2c3b3

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

June 13, 2016

Package DI Number

10801741030496

Quantity per Package

20

Contains DI Package

00801741030499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA