MIRARI Cold Plasma System Insulating Fleece Pouch

Basic Information

• Brand Name: MIRARI Cold Plasma System Insulating Fleece Pouch
• Primary DI: 00860013508623
• Version / Model: GV-FL-01
• Company Name: General Vibronics, LLC
• Labeler DUNS: 020484227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 1
• Public Version Date: 2025-05-08
• Public Version Status: New
• Public Device Record Key: 9a05639b-639e-462a-8b1e-6a03db71eabb

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: 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
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	878.4400	2
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47576	Medium-wave diathermy treatment system generator	A component of a medium-wave diathermy treatment system that generates electromagnetic (EM) energy, in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, applied transcutaneously to provide a deep heat within specific volumes of a patient's body. The energy generated by this device is typically conducted through a hand-operated electrode moved across the treatment area to treat pain, muscle spasms, and joint contractures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013508623	GS1

Premarket Submissions

Submission Number	Supplement Number
K242553	000