Catalog Number

-

Brand Name

Megadyne

Version/Model Number

4010j

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

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

K964176,K964176,K964176

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

d3f55aa0-73df-4288-99fb-0830d2655df9

Public Version Date

June 30, 2021

Public Version Number

4

DI Record Publish Date

September 05, 2018

Package DI Number

30614559105690

Quantity per Package

12

Contains DI Package

10614559105696

Package Discontinue Date

June 30, 2021

Package Status

Not in Commercial Distribution

Package Type

-