Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1033FBR40

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

80239458-73f5-4d1a-936a-0a2c17191fa1

Public Version Date

May 09, 2019

Public Version Number

1

DI Record Publish Date

May 01, 2019

Package DI Number

10818323027829

Quantity per Package

60

Contains DI Package

00818323027822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case