Catalog Number

CL-N2O-8G-UNBOX

Brand Name

Freezpen®

Version/Model Number

8g 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

35df3330-6673-4d36-b15d-f72dd329ca6d

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 15, 2019

Package DI Number

B386CLN2O8GUNCARTON2

Quantity per Package

16

Contains DI Package

B386CLN2O8GUNBOX1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-