Catalog Number

-

Brand Name

Defend

Version/Model Number

MK-4046

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

K020474

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

42ef5c05-1f8d-4e46-aec0-b90e1c1f0b49

Public Version Date

September 27, 2022

Public Version Number

6

DI Record Publish Date

November 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-