Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1033

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

K161282,K161282

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

513f1613-7031-463c-9db6-377d97ae3399

Public Version Date

May 23, 2019

Public Version Number

1

DI Record Publish Date

May 15, 2019

Package DI Number

10818323027898

Quantity per Package

36

Contains DI Package

00818323027891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case