RFDE-VA

Basic Information

• Brand Name: RFDE-VA
• Primary DI: 00817371020052
• Version / Model: RFDE-VA
• Catalog Number: RFDE-VA-1
• Company Name: Thermi
• Labeler DUNS: 021008486
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2022-04-11
• Public Version Status: Update
• Public Device Record Key: 673e8710-a4a8-4a22-9a7b-3035edad5c99

Device Description

RFDE-VA Disposable Radio Frequency Electrode

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: 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
47577	Medium-wave diathermy treatment system electrode, active	A hand-operated electrical conductor that is a component of a medium-wave diathermy treatment system and designed to be moved over the skin surface of a patient by an operator to deliver an electrical current at a pre-set frequency to develop heat in subcutaneous tissues. It is typically designed with permanently attached cables. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817371020052	GS1
Package	10817371020097	GS1	Box	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K130689	000