OneRF Ablation System

Basic Information

• Brand Name: OneRF Ablation System
• Primary DI: 00856895008658
• Version / Model: NSEEG8016-RF
• Company Name: NEUROONE MEDICAL TECHNOLOGIES CORPORATION
• Labeler DUNS: 105937669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-02
• Public Version: 1
• Public Version Date: 2024-12-10
• Public Version Status: New
• Public Device Record Key: 37d6fa1b-891d-4b37-b405-44ce8dba8db1

Device Description

80mm x 16 Contact sEEG - RF Probe

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: MR Unsafe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXI	Probe, Radiofrequency Lesion	Neurology	882.4725	2
GZL	Electrode, Depth	Neurology	882.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32556	Depth electrode	An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.	No	Active
62055	Percutaneous radio-frequency ablation probe, brain-ablation	A semi-flexible, hand-held instrument intended to be percutaneously introduced via a dedicated cannula under stereotactic guidance [e.g., using pre-acquired magnetic resonance imaging (MRI) images and fluoroscopy] to deliver radio-frequency current in a monopolar configuration from a system generator for the surgical ablation of brain tissues (e.g., during amygdalohippocampectomy). It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856895008658	GS1

Customer Contacts

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