Catalog Number

MKH3-2

Brand Name

Ultraproof

Version/Model Number

MKH3-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K133070,K133070,K133070

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

358dc015-a7fe-40b0-ab8f-2ac759036a2e

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 25, 2022

Package DI Number

D832MKH322

Quantity per Package

20

Contains DI Package

D832MKH321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case