Megadyne

Basic Information

• Brand Name: Megadyne
• Primary DI: 10614559105153
• Version / Model: 004225
• Catalog Number: 004225
• Company Name: MEGADYNE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 185444825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-04
• Public Version: 7
• Public Version Date: 2021-06-11
• Public Version Status: Update
• Public Device Record Key: 1cd630c2-d6f6-4837-b4c4-dacd82dfabf2

Device Description

Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm)

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

Sterilization

• Is Sterile: Yes
• 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
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10614559105153	GS1
Package	30614559105157	GS1	BOX	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072559	000

Storage Conditions

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