NEUROMARK™ Device

GUDID 05391537940002

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 a hand-held single-use bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar radiofrequency energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled radiofrequency energy level delivery. The NEUROMARK™ Device is operated via handle, slider and activation switch. The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator. The NEUROMARK™ Device includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK™ Radiofrequency Generator.

NEURENT MEDICAL LIMITED

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 05391537940002
• NIH Device Record Key: bc6a575b-7f9a-4f28-bbfe-59abd204a5b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEUROMARK™ Device
• Version Model Number: FS-002
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	05391537940002 [Primary]
GS1	05391537940019 [Package]; Package: Shipper Box [10 Units]; In Commercial Distribution
GS1	05391537940033 [Package]; Package: Shipper Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212666

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-04
• Device Publish Date: 2022-04-26

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: 2023-02-09 The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolar
• 05391537940002 - NEUROMARK™ Device: 2022-05-04The 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 a hand-held single-use bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar radiofrequency energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled radiofrequency energy level delivery. The NEUROMARK™ Device is operated via handle, slider and activation switch. The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator. The NEUROMARK™ Device includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK™ Radiofrequency Generator.
• 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