Catalog Number

MKS1-2

Brand Name

Plasdent FluidProof Earloop Mask

Version/Model Number

MKS1

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,K133070

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

6a063300-b226-423c-b3d1-d1cdfca0d512

Public Version Date

February 22, 2022

Public Version Number

4

DI Record Publish Date

September 27, 2018

Package DI Number

D832MKS125

Quantity per Package

250

Contains DI Package

D832MKS12

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE