Stimuplex® HNS 12
Stimuplex® HNS 12 Nerv Stimulator with electrode cable / Electrode Cable Ordering-No. 4892070
2manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Stockert Gmbh, Germany |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Manufacturer |
| Record published | 2017-05-04 |
| Record revised | 2026-01-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4892098 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SunMed | SunMed Group Holdings, LLC | 22 |
| Xavant Technology | Xavant Technology (PTY) Ltd | 14 |
| Stimuplex® | B. Braun Medical Inc. | 12 |
| AincA® | Anesthesia Associates, Inc. | 9 |
| Halyard | Avanos Medical, Inc. | 8 |
| Avanos | Avanos Medical, Inc. | 8 |
| Stimpod | Xavant Technology (PTY) Ltd | 6 |
| Multistim Vario | Pajunk Gmbh Medizintechnologie | 6 |
| Multistim Sensor | Pajunk Gmbh Medizintechnologie | 5 |
| MultiStim ECO | Pajunk Gmbh Medizintechnologie | 4 |
| MultiStim Sensor PatientCable | Pajunk Gmbh Medizintechnologie | 4 |
| Temena | Temena GmbH | 2 |
Showing 12 of 19. All products under Stimulator, Nerve, Battery-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070134 | 2007-03-22 |
| K061983 | 2006-11-21 |
| K052313 | 2005-11-17 |
| K003983 | 2001-06-06 |
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.