Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB2029PAK2

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

Yes

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

c84028f4-5070-4c2f-bb1c-282fc1894f92

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Package DI Number

10810041989601

Quantity per Package

100

Contains DI Package

00810041989604

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case