Catalog Number

-

Brand Name

Vivesole

Version/Model Number

INS1023MS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2019

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

55b520c4-c02c-4621-ad28-959e3c5e8eb1

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

March 07, 2019

Package DI Number

10818323026938

Quantity per Package

100

Contains DI Package

00818323026931

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

CASE