Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1054

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

IKX

Product Code Name

Aid, Transfer

Public Device Record Key

2222e297-598c-4d3b-b404-991a2d7bb555

Public Version Date

November 10, 2021

Public Version Number

1

DI Record Publish Date

November 02, 2021

Package DI Number

10810041987898

Quantity per Package

30

Contains DI Package

00810041987891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case