OneRF Ablation System
Generator Accessory - Generator Interface Cable
2manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Cathay Manufacturing Corp. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Neuroone Medical Technologies Corp., United States |
|---|---|
| FDA product code | GXD |
| Device type | Generator, Lesion, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4400 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-03-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NRFGN0001 | In distribution | |
| NRFBK0001 | In distribution | |
| NRFGC0001 | In distribution | |
| NRFFP0001 | In distribution | |
| NRFGS0001 | In distribution | |
| NRFCH0001 | In distribution | |
| NRFPK0001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Generator, Lesion, Radiofrequency | Boston Scientific Neuromodulation Corporation | 68 |
| Generator, Lesion, Radiofrequency | Stryker Leibinger Gmbh & Co. KG | 58 |
| GX1™ | Boston Scientific Neuromodulation Corporation | 7 |
| Accurian | Medtronic Sofamor Danek, Inc. | 7 |
| Multigen 2 | Stryker GmbH | 6 |
| Avanos* | Avanos Medical, Inc. | 4 |
| OWL | Diros Technology, Inc. | 4 |
| NeuroTherm™ | Neurotherm, Inc. | 3 |
| Halyard | Avanos Medical, Inc. | 3 |
| Venom Multigen 2 | Stryker GmbH | 2 |
| Relievant | Relievant Medsystems | 2 |
| IonicRF™ | St. Jude Medical | 2 |
Showing 12 of 26. All products under Generator, Lesion, Radiofrequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231675 | 2023-12-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.