EVO Cable Assembly NEC1602

GUDID 00856895008375

EVO Cable Assembly Only

NEUROONE MEDICAL TECHNOLOGIES CORPORATION

Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode
Primary Device ID00856895008375
NIH Device Record Keyf47a3a6a-15fe-4a33-812d-09efd4ca0c8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVO Cable Assembly
Version Model NumberEVO Cable Assembly
Catalog NumberNEC1602
Company DUNS105937669
Company NameNEUROONE MEDICAL TECHNOLOGIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com
Phone952-426-1383
EmailCustomerService@N1MTC.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856895008375 [Primary]

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-05
Device Publish Date2021-09-27

Devices Manufactured by NEUROONE MEDICAL TECHNOLOGIES CORPORATION

00856895008498 - OneRF Ablation System2024-03-25 RF Ablation Generator
00856895008504 - OneRF Ablation System2024-03-25 Generator Accessory - Cart
00856895008511 - OneRF Ablation System2024-03-25 Generator Accessory - Bin
00856895008528 - OneRF Ablation System2024-03-25 Generator Accessory - Generator Interface Cable
00856895008535 - OneRF Ablation System2024-03-25 Generator Accessory - Foot Pedal
00856895008559 - OneRF Ablation System2024-03-25 Generator Accessory - Handle
00856895008566 - OneRF Ablation System2024-03-25 Temperature Accessory / RF Connector Box
00856895008573 - EVO sEEG Electrode2024-03-25 16mm x 5 Contact sEEG Electrode - RF Probe

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