Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP2063GRYM

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

K183154,K183154

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

5a812328-81a1-4ba9-9bf7-6ea5fc0da949

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 26, 2022

Package DI Number

10810041987515

Quantity per Package

60

Contains DI Package

00810041987518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case