Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP2098

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

a889da70-e790-412b-9c0f-f58403f9a0fa

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Package DI Number

10810041988574

Quantity per Package

40

Contains DI Package

00810041988577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case