Bionen
Hypodermic Needle Electrode for Botox injection (disposable)
2manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Bionen SAS DI Barbara Nencioni & C. |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| 510(k) | K092973 |
| Record published | 2018-09-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Needle gauge 23 to 30 G; length 25 to 75 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0028014 | Needle Gauge 26 G | In distribution |
| 0028113 | Needle Gauge 28 G | In distribution |
| 0028015 | Needle Gauge 26 G | In distribution |
| 0028016 | Needle Gauge 26 G | In distribution |
| 0028522 | Length 25 mm | In distribution |
| 0028013 | Needle Gauge 26 G | In distribution |
| 0028528 | Length 45 mm | In distribution |
| 0028112 | Needle Gauge 28 G | In distribution |
| 0028523 | Length 37 mm | In distribution |
| 0028526 | Length 75 mm | In distribution |
| 0028524 | Length 37 mm | In distribution |
| 0028521 | Length 25 mm | In distribution |
| 0028012 | Needle Gauge 26 G | In distribution |
| 0028527 | Length 33 mm | In distribution |
| 0028018 | Needle Gauge 26 G | In distribution |
| 0028525 | Length 50 mm | In distribution |
| 0028017 | Needle Gauge 25 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Cadwell | Technomed Engineering B.V. | 42 |
| Chalgren | Chalgren Enterprises, Inc. | 42 |
| Rhythmlink® | Rhythmlink International, LLC | 39 |
| Electrode, Needle, Diagnostic Electromyograph | Neurovision Medical Products, Inc. | 38 |
| MediMax Tech | Medimax Tech Inc. | 19 |
| Bio Protech | BIO Protech USA, Inc. | 19 |
| UltraPoint™ | Rochester Electro Medical, Inc. | 18 |
| Natus Neurology | Natus Neurology Incorporated | 13 |
| Neuroguard | Technomed Engineering B.V. | 11 |
| Teca Elite | Natus Manufacturing Limited | 11 |
Showing 12 of 39. All products under Electrode, Needle, Diagnostic Electromyograph
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.