Renuvion®/J-Plasma®

Basic Information

• Brand Name: Renuvion®/J-Plasma®
• Primary DI: 00607151050139
• Version / Model: APYX-JPDFS
• Catalog Number: APYX-JPDFS
• Company Name: APYX MEDICAL CORPORATION
• Labeler DUNS: 101223287
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-23
• Public Version: 3
• Public Version Date: 2023-05-24
• Public Version Status: Update
• Public Device Record Key: 65599da6-17f9-428a-a04f-fed6e9e47ef1

Device Description

Renuvion®/J-Plasma® Footswitch Dual Pedal

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: 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
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	00607151050139	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius