NT2000iX™
Catalogue number RFG-NT-2000, listed by St. Jude Medical, United States, under Generator, Lesion, Radiofrequency. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | St. Jude Medical, United States |
|---|---|
| FDA product code | GXD |
| Device type | Generator, Lesion, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4400 |
| Establishment | Manufacturer, Exporter |
| Record published | 2016-09-20 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -10 to 70 °C; Storage environment temperature -10 to 70 °C; Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 18 to 101 KiloPascal; Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RFG-NT-2000 | 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 |
| OneRF Ablation System | Neuroone Medical Technologies Corp. | 7 |
| 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 |
Showing 12 of 26. All products under Generator, Lesion, Radiofrequency
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| St. Jude Medical, Cardiology Division, Inc. | UDI-DI | 2023-09-28 | Class II | Process change control | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure. | 34 devices | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | UDI-DI | 2021-04-22 | Class II | Process change control | Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission. | 318 units | 2023-02-02 |
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.