Thermi Disposable RF Electrode (Qty1)

Basic Information

• Brand Name: Thermi Disposable RF Electrode (Qty1)
• Primary DI: 00817771028962
• Version / Model: RFDE-G3-50W (Qty 1)
• Catalog Number: RFDE-G3-50W
• Company Name: Celling Biosciences
• Labeler DUNS: 021560394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-17
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: bf6e2410-1ede-4078-869a-49c033ed117c

Device Description

Thermi Disposable RF Electrode - 50W Qty 1

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: Yes
• 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	00817771028962	GS1

Premarket Submissions

Submission Number	Supplement Number
K173582	000