Catalog Number

-

Brand Name

Burkhart Tray Sleeve A 11 5/8 X 14 1/2 (500)

Version/Model Number

72720838

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

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

bb258041-d926-4be5-86e5-97b0e7f0ecc7

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 05, 2018

Package DI Number

10815878020992

Quantity per Package

4

Contains DI Package

00815878020995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-