Catalog Number

251015J

Brand Name

MEGADYNE

Version/Model Number

251015J

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

K200253,K200253,K200253

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

9a7d32ff-df35-4a32-a186-1aecd2d45aac

Public Version Date

June 11, 2021

Public Version Number

6

DI Record Publish Date

August 03, 2020

Package DI Number

30614559105584

Quantity per Package

20

Contains DI Package

10614559105580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX