Catalog Number

MYTN01-11

Brand Name

MYCO

Version/Model Number

MYTN01-11

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

K160271,K160271,K160271

Product Code

MSH

Product Code Name

Respirator, Surgical

Public Device Record Key

2ccc8376-83b6-4526-9d8b-77c04a5c10f0

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

20386120010841

Quantity per Package

6

Contains DI Package

10386120010844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case