Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1079BLKCH

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

ISA

Product Code Name

Massager, Therapeutic, Electric

Public Device Record Key

d9e5958f-aa7c-4b99-97ee-e21325445366

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

March 21, 2019

Package DI Number

10818323027300

Quantity per Package

12

Contains DI Package

00818323027303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case