Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP2099

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

ILH

Product Code Name

Splint, Hand, And Components

Public Device Record Key

4ae90f7a-d881-4768-8fe8-446e65dfb726

Public Version Date

December 10, 2021

Public Version Number

1

DI Record Publish Date

December 02, 2021

Package DI Number

10810041988451

Quantity per Package

40

Contains DI Package

00810041988454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case