Catalog Number

-

Brand Name

Walrus

Version/Model Number

W21770

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

e803bc16-9e48-449c-8713-faac4b2dd5e8

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

October 28, 2016

Package DI Number

813153021187

Quantity per Package

1

Contains DI Package

10813153021184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-