Catalog Number

-

Brand Name

Vive

Version/Model Number

CSH1041PNK

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

KNO

Product Code Name

Accessories, Wheelchair

Public Device Record Key

26c0ad9e-b8f2-4225-ae3c-37c5aece8020

Public Version Date

August 23, 2022

Public Version Number

1

DI Record Publish Date

August 15, 2022

Package DI Number

10810041985382

Quantity per Package

25

Contains DI Package

00810041985385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case