Catalog Number

CL-FPU-35

Brand Name

Freezpen®

Version/Model Number

Freezpen 35G

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K024009

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

ae66dd3e-7fdf-41d3-859a-fe3397e3732f

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-