Catalog Number

-

Brand Name

WXD Surgical Face Mask ( Non-Sterile)

Version/Model Number

WXDKZ0006

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202548,K202548

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

940a306e-755d-4c83-8713-0c0c037619e9

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-