Catalog Number

792100

Brand Name

Bard® Universal Catheterization Tray

Version/Model Number

792100

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

OHR

Product Code Name

Catheter care tray

Public Device Record Key

21e2c080-1fb4-4cd0-af01-c19aa22b08fe

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

10801741029643

Quantity per Package

20

Contains DI Package

00801741029646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA