Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1019L2PAK

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

cf5657b8-78ea-47db-8897-774fae6bb429

Public Version Date

October 04, 2022

Public Version Number

2

DI Record Publish Date

July 03, 2022

Package DI Number

10850041211951

Quantity per Package

120

Contains DI Package

00850041211954

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case