Catalog Number

CUR384S5CT

Brand Name

Curad

Version/Model Number

CUR384S5CT

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

Yes

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

5a12b804-faea-4b29-b302-e30762a525ab

Public Version Date

April 23, 2021

Public Version Number

1

DI Record Publish Date

April 15, 2021

Package DI Number

40888277359865

Quantity per Package

24

Contains DI Package

30888277359868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

RETAIL OUTER PACK