Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2027

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

310d3932-db15-491c-9de6-182080a8b4a6

Public Version Date

January 17, 2020

Public Version Number

1

DI Record Publish Date

January 09, 2020

Package DI Number

10810041981094

Quantity per Package

1

Contains DI Package

00810041981097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case