Catalog Number

-

Brand Name

Walgreens

Version/Model Number

385894

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

7d529aba-718c-4b4c-89f5-5ae275ad22eb

Public Version Date

July 30, 2020

Public Version Number

1

DI Record Publish Date

July 22, 2020

Package DI Number

10311917174546

Quantity per Package

24

Contains DI Package

00311917174549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case