Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA1060GRYL

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

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

eaf1b40d-3b46-4bc4-91f0-4922b7c86011

Public Version Date

July 30, 2018

Public Version Number

1

DI Record Publish Date

June 29, 2018

Package DI Number

10818323020509

Quantity per Package

6

Contains DI Package

00818323020502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-