Catalog Number

MEGEN1

Brand Name

MEGADYNE

Version/Model Number

MEGEN1

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

K193145

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

e6810f06-0798-4e82-a7e8-d1973d4bfb46

Public Version Date

April 20, 2022

Public Version Number

6

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-