Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1052PAK2

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

f46dd140-fd0c-441b-b807-5ce5e3ea01a1

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 26, 2022

Package DI Number

00818323024357

Quantity per Package

100

Contains DI Package

00850041211091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case