NeuroTherm™

Basic Information

• Brand Name: NeuroTherm™
• Primary DI: 05415067021182
• Version / Model: RFE-15
• Catalog Number: RFE-15
• Company Name: NEUROTHERM, INC.
• Labeler DUNS: 124023552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-30
• Public Version: 3
• Public Version Date: 2023-08-09
• Public Version Status: Update
• Public Device Record Key: 045f7caa-69ef-4e08-99ec-fcb574b6454d

Device Description

Reusable Radiofrequency Electrode

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXI	PROBE, RADIOFREQUENCY LESION	Neurology	882.4725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62025	Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable	A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067021182	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place; avoid exposure to extreme temperatures.