Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP1052

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

a46a5ce9-bb1e-4cca-bdf4-cd9078264a9e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 19, 2019

Package DI Number

10818323020066

Quantity per Package

100

Contains DI Package

00818323020069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case