Catalog Number

ACC-CDT04

Brand Name

truFreeze

Version/Model Number

CD6-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 04, 2017

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162695

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

933426b4-ccb8-49d2-8e07-17e641797897

Public Version Date

April 06, 2022

Public Version Number

5

DI Record Publish Date

March 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-