Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2043

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

752c5c8b-6a9f-41dc-87b2-73a3131397e9

Public Version Date

April 15, 2020

Public Version Number

1

DI Record Publish Date

April 07, 2020

Package DI Number

10810041981803

Quantity per Package

1

Contains DI Package

00810041981806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case