Catalog Number

-

Brand Name

S&J

Version/Model Number

M2223

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211462

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

d4bd9bf7-d3cd-4303-a6dd-476b99334718

Public Version Date

April 11, 2022

Public Version Number

1

DI Record Publish Date

April 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-