Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB2087BLK2W105L

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

5449b7d2-4280-4ec4-b618-c2a13f9bcdf9

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 26, 2022

Package DI Number

10850041211555

Quantity per Package

20

Contains DI Package

00850041211558

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case