Catalog Number

-

Brand Name

SmoothCool

Version/Model Number

SmoothCool

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

K092326,K092326

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

70d97f5b-7268-42aa-9189-830ee525204b

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

8800020103024

Quantity per Package

1

Contains DI Package

08800020103017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden crate