NEUROMARK™ Device
Basic Information
- Brand Name
- NEUROMARK™ Device
- Primary DI
- 05391537940002
- Version / Model
- FS-002
- Company Name
- NEURENT MEDICAL LIMITED
- Labeler DUNS
- 985640950
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-26
- Public Version
- 6
- Public Version Date
- 2024-01-09
- Public Version Status
- Update
- Public Device Record Key
- bc6a575b-7f9a-4f28-bbfe-59abd204a5b4
- Distribution End Date
- 2024-01-05
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391537940002 | GS1 | ||||
| Package | 05391537940019 | GS1 | Shipper Box | 10 | Not in Commercial Distribution | 2023-01-11 |
| Package | 05391537940033 | GS1 | Shipper Box | 5 | Not in Commercial Distribution | 2022-04-26 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212666 | 000 |