AccessGUDID - DEVICE: NEUROMARK System (05391537940187)

GUDID

Device Identifier (DI) Information

Brand Name: NEUROMARK System
Version or Model: NMK00301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NMK00301
Company Name: NEURENT MEDICAL LIMITED

Primary DI Number: 05391537940187
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985640950 *Terms of Use

Device Description: The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [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 electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The NEUROMARK Device is operated via handle, slider and activation button. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console only and is connected via a flexible interface cable.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44776	Electrosurgical system	An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250048	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 20dd81e2-07fa-493e-aa62-b35c40445662
Public Version Date: June 10, 2025
Public Version Number: 1
DI Record Publish Date: June 02, 2025