Catalog Number

HP-003

Brand Name

Dermal Cooling System

Version/Model Number

HP-003

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171398

Product Code

GEH

Product Code Name

UNIT, CRYOSURGICAL, ACCESSORIES

Public Device Record Key

f64ae90e-17a3-47ab-88f8-3179ce4c941a

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-