Catalog Number

-

Brand Name

AOK

Version/Model Number

20190019

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

K201517,K201517,K201517,K201517

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

4a4ad099-82da-46bb-8d42-614927d961eb

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Package DI Number

26973869540025

Quantity per Package

20

Contains DI Package

16973869540028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box