FDA.reportPublic FDA data

OneRF Ablation System

Primary DI
00856895008504
Brand
OneRF Ablation System
Company
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Model
NRFGS0001
Device description
Generator Accessory - Cart
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXDGenerator, Lesion, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856895008504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856895008504008568950085048568950085040856895008504

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105937669
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856895008153One RF Ablation SystemNRFPK0001-TNRF2025-09-01
00856895008139One RF Ablation System2708-TNRF2025-08-20
00856895008146One RF Ablation System1605-TNRF2025-08-20
00856895008634OneRF Ablation SystemNSEEG6216-RF2024-12-02
00856895008641OneRF Ablation SystemNSEEG6916-RF2024-12-02
00856895008658OneRF Ablation SystemNSEEG8016-RF2024-12-02
00856895008498OneRF Ablation SystemNRFGN00012024-03-15
00856895008511OneRF Ablation SystemNRFBK00012024-03-15
00856895008528OneRF Ablation SystemNRFGC00012024-03-15
00856895008535OneRF Ablation SystemNRFFP00012024-03-15
00856895008559OneRF Ablation SystemNRFCH00012024-03-15
00856895008566OneRF Ablation SystemNRFPK00012024-03-15
00856895008573EVO sEEG ElectrodeNSEEG1605-RF2024-03-15
00856895008580EVO sEEG ElectrodeNSEEG2708-RF2024-03-15
00856895008597EVO sEEG ElectrodeNSEEG3410-RF2024-03-15
00856895008603EVO sEEG ElectrodeNSEEG4112-RF2024-03-15
00856895008610EVO sEEG ElectrodeNSEEG4814-RF2024-03-15
00856895008627EVO sEEG ElectrodeNSEEG5516-RF2024-03-15
00856895008238EVO sEEG Electrode16mm x 5 Contact sEEG ElectrodeNSEEG16052021-09-27
00856895008252EVO sEEG Electrode33.5mm x 10 Contact sEEG ElectrodeNSEEG34102021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
05415067049650NAST. JUDE MEDICAL, INC.GXD2024-03-26
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
10195327563424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
40195327563425Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
05415067034519N/AST. JUDE MEDICAL, INC.GXD2023-10-25
15415067034516N/AST. JUDE MEDICAL, INC.GXD2023-10-25
00825114000032OWLDiros Technology IncGXD2023-06-19
00852454006288RelievantRelievant Medsystems, Inc.GXD2022-12-09
00193493000692COOLIEF* Quad Pump Connector CableAvanos Medical, Inc.GXD2022-10-17
00193493000340AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000357AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000401AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493000418AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493473021COOLIEF* Basic-R GeneratorAvanos Medical, Inc.GXD2021-01-27
00193493473038COOLIEF* Cooled RF Advanced-R GeneratorAvanos Medical, Inc.GXD2021-01-27
05415067029317IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-14
05415067033833IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-11
00193493473014COOLIEF* Cooled RF Advanced GeneratorAvanos Medical, Inc.GXD2020-10-16