Catalog Number

-

Brand Name

SmoothCool HR

Version/Model Number

SmoothCool HR

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082911,K082911

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

37183f61-eaa0-496b-b3d6-5d6119ccc8d5

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

8800020106025

Quantity per Package

1

Contains DI Package

08800020106018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden crate