Catalog Number

802100

Brand Name

Bardia Urethral Catheter Tray

Version/Model Number

802100

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

8c84e7db-bdfa-4614-a82e-36d54cd218ff

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

10801741051187

Quantity per Package

20

Contains DI Package

00801741051180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA