Catalog Number

-

Brand Name

Burkhart Polar Breeze Refrigerant Spray 6oz

Version/Model Number

72720585

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K930764,K930764

Product Code

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

33efff10-f4a8-4b6e-8997-afaeb47f6760

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10854212006568

Quantity per Package

12

Contains DI Package

00854212006561

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-