Catalog Number

-

Brand Name

LUTRONIC GENIUS

Version/Model Number

GENIUS G U110V

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

e6237474-2b1f-4633-acb2-8eb965d35bde

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2018

Package DI Number

08809447652245

Quantity per Package

1

Contains DI Package

08809447652238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Case