Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1043WHT

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

K170205,K183288,K170205,K183288

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

783d1c9f-3422-4404-9b84-5e7f0233f212

Public Version Date

February 24, 2021

Public Version Number

8

DI Record Publish Date

January 11, 2018

Package DI Number

10818323021858

Quantity per Package

40

Contains DI Package

00818323021851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case