Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1070PAK2

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

ITQ

Product Code Name

Joint, Knee, External Brace

Public Device Record Key

0c2e5a8b-39c6-4df4-a287-cce6e6234fdd

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

10850041211135

Quantity per Package

6

Contains DI Package

00850041211138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case