Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP1069

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

f584e1d6-070c-4ac7-a1e6-904e8cc1cb9b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2019

Package DI Number

10818323029496

Quantity per Package

1

Contains DI Package

00818323029499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case