Catalog Number

-

Brand Name

Burkhart Dental Supply

Version/Model Number

72720528

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

f901c416-e3eb-4df4-bbd1-1e8c7b563442

Public Version Date

March 08, 2021

Public Version Number

3

DI Record Publish Date

December 10, 2020

Package DI Number

10815878021166

Quantity per Package

10

Contains DI Package

00815878021169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case