Catalog Number

AW004

Brand Name

Optiheal Soft Silicone Tape

Version/Model Number

AW004

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

880e2aee-a625-4e84-85ae-405e93d321c4

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 19, 2021

Package DI Number

05060247390635

Quantity per Package

125

Contains DI Package

05060247396040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-