Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB2026

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

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

d7617872-33be-47e4-80e7-dcec393e5e5e

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Package DI Number

10810041983319

Quantity per Package

50

Contains DI Package

00810041983312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case