NEUROMARK® Radiofrequency Console

GUDID 05391537940118

The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Console via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure; directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.

NEURENT MEDICAL LIMITED

Electrosurgical system

• Primary Device ID: 05391537940118
• NIH Device Record Key: cec4243a-303e-46d1-b5ab-6a6b8c5a7edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEUROMARK® Radiofrequency Console
• Version Model Number: 010-00089-000
• Company DUNS: 985640950
• Company Name: NEURENT MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391537940118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222032

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-09
• Device Publish Date: 2023-02-01

Devices Manufactured by NEURENT MEDICAL LIMITED

• 05391537940095 - NEUROMARK® Device: 2023-02-09 The NEUROMARK System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolar
• 05391537940118 - NEUROMARK® Radiofrequency Console: 2023-02-09The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Console via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure; directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.
• 05391537940118 - NEUROMARK® Radiofrequency Console: 2023-02-09 The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolar
• 05391537940002 - NEUROMARK™ Device: 2022-05-04 The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in oto
• 05391537940026 - NEUROMARK™ Radiofrequency Generator: 2022-05-04 The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in oto