Catalog Number

10000

Brand Name

Scar Fx

Version/Model Number

10000

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Public Device Record Key

3bbba37f-052f-40df-b852-972bdbdc9910

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

00642790240008

Quantity per Package

2

Contains DI Package

00642790100005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Unit Carton