Generator, Lesion, Radiofrequency
Bipolar Adapter F. US Standard Cable
2manufacturers in China registered for this device type
58catalogue numbers in this listing
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 | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | GXD |
| Device type | Generator, Lesion, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4400 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2021-04-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 7 to 24 cm; width 0.2 to 2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-82201 | Length 19.0 cm | In distribution |
| 12-30174 | Length 20.0 cm | In distribution |
| 12-04240 | Length 17.0 cm | In distribution |
| 92-12074 | Length 16.0 cm | In distribution |
| 12-30172 | Width 0.7 mm | In distribution |
| 12-30372 | Length 24.0 cm | In distribution |
| 12-82255 | Width 1.2 mm | In distribution |
| 12-82153 | Width 0.7 mm | In distribution |
| 12-30076 | Width 2.0 mm | In distribution |
| 12-04239 | Diameter: 1.2 Millimeter | In distribution |
| 12-30176 | Width 2.0 mm | In distribution |
| 12-30277 | Length 22.0 cm | In distribution |
| 12-82126 | Length 16.0 cm | In distribution |
| 12-82261 | Length 19.0 cm | In distribution |
| 12-04230 | Length 7.0 cm | In distribution |
| 12-82151 | Length 16.0 cm | In distribution |
| 12-30072 | Width 0.7 mm | In distribution |
| 12-82257 | Width 1.8 mm | In distribution |
| 12-04235 | Diameter: 2.5 Millimeter | In distribution |
| 92-12070 | Width 0.2 mm | In distribution |
| 12-30270 | Length 22.0 cm | In distribution |
| 12-82263 | Width 0.7 mm | In distribution |
| 12-30274 | Length 22.0 cm | In distribution |
| 12-82253 | Length 19.0 cm | In distribution |
| 12-82373 | Width 2.0 mm | In distribution |
| 12-30074 | Width 1.2 mm | In distribution |
| 12-82252 | Width 0.5 mm | In distribution |
| 12-04237 | Length 13.5 cm | In distribution |
| 12-82222 | Length 19.0 cm | In distribution |
| 12-30276 | Length 22.0 cm | In distribution |
| 12-30374 | Length 24.0 cm | In distribution |
| 12-30170 | Length 20.0 cm | In distribution |
| 12-04238 | Diameter: 2.5 Millimeter | In distribution |
| 92-12076 | Length 16.0 cm | In distribution |
| 12-82224 | Width 1.3 mm | In distribution |
| 12-82800 | In distribution | |
| 12-30272 | Length 22.0 cm | In distribution |
| 12-82104 | Width 1.2 mm | In distribution |
| 12-04250 | Length 15.0 cm | In distribution |
| 12-30370 | Length 24.0 cm | In distribution |
| 12-82251 | Width 0.2 mm | In distribution |
| 12-82001 | Width 0.2 mm | In distribution |
| 12-82228 | Length 19.0 cm | In distribution |
| 12-82124 | Width 1.2 mm | In distribution |
| 12-82272 | Width 1.8 mm | In distribution |
| 92-12072 | Width 0.7 mm | In distribution |
| 12-04231 | Length 7.0 cm | In distribution |
| 12-04241 | Diameter: 2.5 Millimeter | In distribution |
| 12-04232 | Diameter: 2.5 Millimeter | In distribution |
| 12-04233 | Diameter: 1.2 Millimeter | In distribution |
| 12-30070 | Length 18.0 cm | In distribution |
| 12-82226 | Width 2.0 mm | In distribution |
| 12-30179 | Width 0.2 mm | In distribution |
| 12-30180 | Width 0.7 mm | In distribution |
| 12-04236 | Length 13.5 cm | In distribution |
| 12-82002 | Length 12.0 cm | In distribution |
| 12-82202 | Length 19.0 cm | In distribution |
| 12-04234 | Diameter: 2.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Generator, Lesion, Radiofrequency | Boston Scientific Neuromodulation Corporation | 68 |
| 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 |
| IonicRF™ | St. Jude Medical | 2 |
Showing 12 of 26. All products under Generator, Lesion, Radiofrequency
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.