Catalog Number

-

Brand Name

CoolTouch

Version/Model Number

7435-0200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 2018

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

357319f6-85f4-4b29-b7cf-2a35f440e652

Public Version Date

August 06, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10859932006300

Quantity per Package

24

Contains DI Package

00859932006303

Package Discontinue Date

September 26, 2018

Package Status

Not in Commercial Distribution

Package Type

Box