Catalog Number

CL-FPU-18

Brand Name

Freezpen®

Version/Model Number

Freezpen 16G

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

-

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

065ef05e-7a41-4627-aeb2-c1de6b1cc3bc

Public Version Date

May 23, 2019

Public Version Number

1

DI Record Publish Date

May 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-