Catalog Number

-

Brand Name

Vive Mobility

Version/Model Number

MOB1057BLU

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

3e95b27c-6936-4702-90b9-5e8b99378272

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 02, 2022

Package DI Number

10810113570171

Quantity per Package

1

Contains DI Package

00810113570174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case