Catalog Number

-

Brand Name

CoolTouch

Version/Model Number

9000-0460

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

297d470a-5b0f-4471-a668-6db943ac283a

Public Version Date

August 06, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10859932006294

Quantity per Package

5

Contains DI Package

00859932006297

Package Discontinue Date

September 26, 2018

Package Status

Not in Commercial Distribution

Package Type

Box