Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP1058

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2020

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

e846ad58-4cdd-4a97-a6ae-a93eb8026bd1

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 20, 2019

Package DI Number

10818323020677

Quantity per Package

40

Contains DI Package

00081832302067

Package Discontinue Date

July 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Case