Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2028

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2022

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

2f41e81c-c3be-4367-841b-c4f01ab49e66

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

January 09, 2020

Package DI Number

10810041981100

Quantity per Package

1

Contains DI Package

00810041981103

Package Discontinue Date

October 31, 2022

Package Status

Not in Commercial Distribution

Package Type

Case