Catalog Number

MYEL 20000

Brand Name

MYCO

Version/Model Number

MYEL 20000

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

K160269,K160269,K160269

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

8207e6d6-79db-4488-b9a6-7b821ae48941

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Package DI Number

20386120010933

Quantity per Package

30

Contains DI Package

10386120010936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case