Catalog Number

-

Brand Name

Surgical Face Mask

Version/Model Number

533-005

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

K212610,K212610,K212610

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

3b888de3-7a58-4c21-941e-15822021376f

Public Version Date

March 01, 2022

Public Version Number

1

DI Record Publish Date

February 21, 2022

Package DI Number

16973062321585

Quantity per Package

4

Contains DI Package

06973062321588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-