Catalog Number

-

Brand Name

Walrus

Version/Model Number

W22371

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

b92f1f8d-048f-45f9-a6d7-1770336c05f3

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

813153021316

Quantity per Package

1

Contains DI Package

10813153021313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-