Catalog Number

-

Brand Name

Me

Version/Model Number

HU-CO00721

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

06bfbbfe-869a-4adc-a5e1-afcc2dbee930

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20806248006903

Quantity per Package

2

Contains DI Package

10806248006906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Maste carton