Catalog Number

-

Brand Name

CROSSWALK

Version/Model Number

PSC35090B

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"

-

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

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

c8de25fa-b838-4129-8cf4-fcace6cd2016

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

Package DI Number

14547327133842

Quantity per Package

5

Contains DI Package

04547327133845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-