Catalog Number

N/A

Brand Name

Compound W®

Version/Model Number

NitroFreeze Yellow CWUS009101

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

bc8107fd-2607-448a-a4c7-21545bc81cc2

Public Version Date

January 24, 2020

Public Version Number

1

DI Record Publish Date

January 16, 2020

Package DI Number

10075137000145

Quantity per Package

6

Contains DI Package

00075137000148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping carton