Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1011N

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

1a350192-beb0-4e3b-8b63-86a3f890f1ce

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

November 08, 2018

Package DI Number

10818323020028

Quantity per Package

24

Contains DI Package

00818323020021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case