MEGADYNE

Basic Information

• Brand Name: MEGADYNE
• Primary DI: 10614559105634
• Version / Model: 1459J
• Catalog Number: 1459J
• Company Name: MEGADYNE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 185444825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 6
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 67e7bffb-630b-4827-a5a2-80b7550b045c

Device Description

Ethicon Megadyne Round Bipolar Footswitch

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10614559105634	GS1

Premarket Submissions

Submission Number	Supplement Number
K193145	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity