Catalog Number

CL-N2O-8G-BOX

Brand Name

Freezpen

Version/Model Number

8g N2O cartridges for Freezpen

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K024009,K024009,K024009

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

38734934-6f34-49e5-856d-21864d276097

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

B386CLN2O8GCARTON2

Quantity per Package

16

Contains DI Package

B386CLN2O8GBOX1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-