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

K213484,K213484

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

e66a3790-f7eb-4f69-849d-996197592992

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

08800020102720

Quantity per Package

1

Contains DI Package

08800020102737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

wooden crate