Catalog Number

MK2-2

Brand Name

Plasdent DuralProof Earloop Mask

Version/Model Number

MK2

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

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

bc1c6971-a359-44b7-842b-36ea3601c60d

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 28, 2018

Package DI Number

D832MK225

Quantity per Package

20

Contains DI Package

D832MK221

Package Discontinue Date

April 04, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE