Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2001

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

ITW

Product Code Name

Joint, Ankle, External Brace

Public Device Record Key

c52c14c9-0701-4ccf-8f29-5f589511e66a

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

August 15, 2019

Package DI Number

10818323028796

Quantity per Package

100

Contains DI Package

00818323028799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case