Catalog Number

AW005

Brand Name

Optiheal Silicone Wound Recovery Strips

Version/Model Number

AW005

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

32cc8760-c1b6-4630-bfb7-d0d5d17a6659

Public Version Date

January 27, 2021

Public Version Number

1

DI Record Publish Date

January 19, 2021

Package DI Number

05060247390659

Quantity per Package

27

Contains DI Package

05060247395050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-