Catalog Number

-

Brand Name

Burkhart Select Earloop Mask - Pink (50)

Version/Model Number

72722046

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

b8a9681a-fc8b-4913-a549-b75baeecf0f7

Public Version Date

October 07, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

10815878020084

Quantity per Package

10

Contains DI Package

00815878020087

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-