Catalog Number

-

Brand Name

VIVE

Version/Model Number

MOB1033

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITJ

Product Code Name

Walker, Mechanical

Public Device Record Key

7e671156-9e19-4e36-bcbf-99529dc43909

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 02, 2019

Package DI Number

10818323029588

Quantity per Package

1

Contains DI Package

00818323029581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case