Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2018

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 30, 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

MHW

Product Code Name

Dressing, Compression

Public Device Record Key

89495c0a-7f51-478f-85de-b0d12b851890

Public Version Date

October 04, 2022

Public Version Number

2

DI Record Publish Date

March 18, 2020

Package DI Number

10810041981636

Quantity per Package

100

Contains DI Package

00810041981639

Package Discontinue Date

November 30, 2022

Package Status

In Commercial Distribution

Package Type

Case