Catalog Number

-

Brand Name

Vivesole

Version/Model Number

INS1028

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

KNP

Product Code Name

Orthosis, Corrective Shoe

Public Device Record Key

282e9f11-d4f5-4d77-988d-53a29bbdb9b7

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

March 12, 2019

Package DI Number

10818323027096

Quantity per Package

120

Contains DI Package

00818323027099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case