Megadyne

Basic Information

• Brand Name: Megadyne
• Primary DI: 10614559103708
• Version / Model: C117MBN
• Company Name: MEGADYNE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 185444825
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-14
• Public Version: 8
• Public Version Date: 2021-03-31
• Public Version Status: Update
• Public Device Record Key: 2b60b614-ade3-4f81-86b7-3c5cbe4083a1
• Distribution End Date: 2021-03-31

Device Description

E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 4.72 inch, Custom, Modified Extended Insulation, Bulk NonSterile

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30614559103702	GS1		100	Not in Commercial Distribution	2021-03-31
Primary	10614559103708	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K081791	000
K913281	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity