Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB2029BLK

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

K200237,K200237

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

b56a2557-3146-4843-b5a0-1ef84e83fe16

Public Version Date

April 15, 2021

Public Version Number

1

DI Record Publish Date

April 07, 2021

Package DI Number

10810041985702

Quantity per Package

60

Contains DI Package

00810041985705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case