Catalog Number

-

Brand Name

WYZ Face Mask

Version/Model Number

2121

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

1c7239b0-8878-4c08-8720-5e39c9fc0e55

Public Version Date

January 18, 2021

Public Version Number

1

DI Record Publish Date

January 09, 2021

Package DI Number

00860004437840

Quantity per Package

40

Contains DI Package

00860004437833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case