Catalog Number

-

Brand Name

MEO

Version/Model Number

17.5×9.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 18, 2056

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

K210870

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

a2839108-29d0-444f-bad0-6259576fd282

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-