Catalog Number

HP-005

Brand Name

Dermal Cooling System

Version/Model Number

HP-005

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

a8332ba2-9e4a-4410-9375-78abf0a0ba0a

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-