Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2022

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

IQE

Product Code Name

Orthosis, Lumbar

Public Device Record Key

7af791ed-8046-40d2-a36b-b14a9371528e

Public Version Date

March 18, 2020

Public Version Number

1

DI Record Publish Date

March 10, 2020

Package DI Number

10810041981575

Quantity per Package

6

Contains DI Package

00810041981578

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case