Catalog Number

004125

Brand Name

Megadyne

Version/Model Number

004125

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

Yes

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

K072559,K072559

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

aa10c086-781e-4a69-815f-8a60acbd2505

Public Version Date

June 11, 2021

Public Version Number

7

DI Record Publish Date

September 04, 2018

Package DI Number

30614559105140

Quantity per Package

25

Contains DI Package

10614559105146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX