Catalog Number

-

Brand Name

ViveSole

Version/Model Number

INS1037

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

OHI

Product Code Name

Orthosis, Foot Drop

Public Device Record Key

b7faf85a-307f-4f66-8658-8142882ebdad

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 02, 2022

Package DI Number

10818323025559

Quantity per Package

78

Contains DI Package

00818323025552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case