Catalog Number

-

Brand Name

WYZ Face Mask

Version/Model Number

2111

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

e0e6be19-3e72-403c-97d4-eb18c0aa809e

Public Version Date

January 26, 2021

Public Version Number

1

DI Record Publish Date

January 18, 2021

Package DI Number

00860004437871

Quantity per Package

40

Contains DI Package

00860004437864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case