Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1081L

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

MHW

Product Code Name

Dressing, Compression

Public Device Record Key

9b3ab62c-1cd6-422c-b1c0-c43947866753

Public Version Date

October 07, 2019

Public Version Number

2

DI Record Publish Date

March 18, 2019

Package DI Number

10818323027225

Quantity per Package

42

Contains DI Package

00818323027228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case