Catalog Number

SDSCRSAM-3G

Brand Name

SilDerm Scar Gel Sachet

Version/Model Number

3g

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

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Public Device Record Key

6f72f939-18c3-4d8a-8898-353570557d38

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

25060295491227

Quantity per Package

20

Contains DI Package

15060295491220

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box