Catalog Number

66023135

Brand Name

DURAMAX S Silicone super absorbent dressing

Version/Model Number

66023135

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

1bb0d010-b07e-4459-8485-741567eab308

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Package DI Number

05000223500894

Quantity per Package

10

Contains DI Package

05000223500887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton