Catalog Number

-

Brand Name

SCARAWAY SILICONE GEL 20G

Version/Model Number

11A3QSAC1

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

Yes

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

aaa6dbab-0911-43d2-a9bb-5720bc5a9a5b

Public Version Date

March 25, 2021

Public Version Number

1

DI Record Publish Date

March 17, 2021

Package DI Number

00070030165536

Quantity per Package

1

Contains DI Package

00070030511739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER