Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP2095

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

FQL

Product Code Name

Stocking, Medical Support (For General Medical Purposes)

Public Device Record Key

a6f8bb18-af9d-488f-bb4c-3d31835e41fa

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Package DI Number

10810041989144

Quantity per Package

100

Contains DI Package

00810041989147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case