Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 26, 2022

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

51562b68-b1d3-4f57-b4bf-7147e674347b

Public Version Date

October 26, 2022

Public Version Number

6

DI Record Publish Date

August 28, 2019

Package DI Number

10818323028734

Quantity per Package

1

Contains DI Package

00818323028737

Package Discontinue Date

August 31, 2022

Package Status

Not in Commercial Distribution

Package Type

Case