Catalog Number

AW007

Brand Name

Optiheal Hydration Multi Purpose Dressing

Version/Model Number

AW007

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

5f8dcc92-8e56-4b61-9686-43860da07e45

Public Version Date

January 27, 2021

Public Version Number

1

DI Record Publish Date

January 19, 2021

Package DI Number

05060247390642

Quantity per Package

90

Contains DI Package

05060247393070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-