Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1008

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

59aa5440-ae77-49ef-beed-22dd3629e8a7

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

January 10, 2019

Package DI Number

10818323020004

Quantity per Package

40

Contains DI Package

00818323020007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case