Catalog Number

-

Brand Name

DemeMASK

Version/Model Number

DT-MSK-003

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"

Yes

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

7b62e326-0cdd-45f2-b55c-29d4787ce8cf

Public Version Date

July 05, 2022

Public Version Number

1

DI Record Publish Date

June 27, 2022

Package DI Number

30652927727792

Quantity per Package

2500

Contains DI Package

10652927727798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case