Catalog Number

-

Brand Name

Burkhart Level 3 Earloop Mask w/Chin Fit, White (50)

Version/Model Number

72720816

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

8b904457-6a9d-4602-befb-401f15a9d10e

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

June 30, 2017

Package DI Number

00815878020650

Quantity per Package

3

Contains DI Package

00815878020599

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sample