Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1006BLK

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"

Yes

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

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

caac5bc4-4395-4112-a069-8d1d68981668

Public Version Date

April 25, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

10861470000399

Quantity per Package

20

Contains DI Package

00861470000392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case