Catalog Number

-

Brand Name

Vivesole

Version/Model Number

INS1010S

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

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

b928f7c5-4578-447a-acdb-4ade6b19ff5f

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

March 06, 2019

Package DI Number

10818323026853

Quantity per Package

100

Contains DI Package

00818323026856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case