FDA.reportPublic FDA data

OneRF Ablation System

Primary DI
00856895008641
Brand
OneRF Ablation System
Company
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Model
NSEEG6916-RF
Device description
68.5mm x 16 Contact sEEG - RF Probe
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2
GZLElectrode, DepthNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856895008641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856895008641008568950086418568950086410856895008641

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, brain-ablationA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-426-1383CustomerService@N1MTC.com

Regulatory Flags#

DUNS number
105937669
Device count
1
Lot or batch
true
Expiration 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
00856895008658OneRF Ablation SystemNSEEG8016-RF2024-12-02
00856895008498OneRF Ablation SystemNRFGN00012024-03-15
00856895008504OneRF Ablation SystemNRFGS00012024-03-15
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
00841823111029Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-06-03
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
10873263009625microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
10873263009496microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10873263009410microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
10873263008789microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008796microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008802microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008819microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008826microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008833microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008840microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008857microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008871microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
10873263008888microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008918microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
10873263009250microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10873263009205microTargeting™ ElectrodeFHC, INC.GZL2024-04-12
27290114060879NeuroNav with MER HeadstageALPHA OMEGA ENGINEERING CO. LTD.GZL2024-01-08
27290114061364NeuroNav Pelican CaseALPHA OMEGA ENGINEERING CO. LTD.GZL2024-01-08
27290114061371Universal DBS holder silicone sleeve - Pack of 5ALPHA OMEGA ENGINEERING CO. LTD.GZL2024-01-08
27290114061388Universal LeadConfirm cable holder silicone sleeve - Pack of 5ALPHA OMEGA ENGINEERING CO. LTD.GZL2024-01-08
37290114061408Frame adapter thumb screw - Pack of 3ALPHA OMEGA ENGINEERING CO. LTD.GZL2024-01-08
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07