Catalog Number

MYEL 30000

Brand Name

MYCO

Version/Model Number

MYEL 30000

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

1229008f-67b6-42b4-9a25-3da61125e770

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

20386120010865

Quantity per Package

30

Contains DI Package

10386120010868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case