Catalog Number

774415

Brand Name

Bard® Urethral Catheterization Tray with Red Rubber Catheter

Version/Model Number

774415

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

aa1bc55e-72f8-4fe7-b9f0-8816d4294d3a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 29, 2016

Package DI Number

10801741040228

Quantity per Package

20

Contains DI Package

00801741040221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA