Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1033PIN

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

cb7b5508-9371-427c-8f49-a6610c8f3b94

Public Version Date

October 11, 2018

Public Version Number

4

DI Record Publish Date

October 03, 2017

Package DI Number

20818323020896

Quantity per Package

36

Contains DI Package

10818323020899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case