Catalog Number

-

Brand Name

Vive

Version/Model Number

MOB1011BLU

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

IPS

Product Code Name

Cane

Public Device Record Key

5772f509-a69a-44c5-8ea2-8a7f90ba4b15

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 2018

Package DI Number

10818323025177

Quantity per Package

20

Contains DI Package

00818323025170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case