Catalog Number

-

Brand Name

Vive

Version/Model Number

MOB1028

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITI

Product Code Name

Wheelchair, Powered

Public Device Record Key

71b8f4c6-00a5-40a4-bdb2-4925dd608ceb

Public Version Date

June 11, 2019

Public Version Number

1

DI Record Publish Date

June 03, 2019

Package DI Number

10818323028000

Quantity per Package

1

Contains DI Package

00818323028003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case