Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1049GRY

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

9a14660d-6fe9-4d91-ab71-35b32e88dc12

Public Version Date

July 18, 2022

Public Version Number

2

DI Record Publish Date

May 01, 2018

Package DI Number

10818323022251

Quantity per Package

1

Contains DI Package

00818323022254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case