Catalog Number

CR-RC1

Brand Name

COOL RENEWAL

Version/Model Number

CR-RC1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161296

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

cc27174c-667e-4a0e-8e09-81f5e24be6b3

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-