Megadyne

Basic Information

• Brand Name: Megadyne
• Primary DI: 10614559101247
• Version / Model: 0690S
• Catalog Number: 0690S
• Company Name: MEGADYNE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 185444825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-11
• Public Version: 10
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 21c67eec-4aad-48f2-b187-8004c6e48d70

Device Description

Electrosurgical Laparoscopic Electrode with Indicator, 32 cm., Reusable, for use with foot control pedal and MEGAtips

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
62061	Endoscopic electrosurgical electrode, monopolar, reusable	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10614559101247	GS1
Package	50614559101245	GS1	CASE	80	In Commercial Distribution
Package	30614559101241	GS1	BOX	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K943055	000

Storage Conditions

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