Neurosign V4
Disposable Bipolar Probe; Precision 2 x 70mm x 0.75mm electrodes; 1.9m twisted wire with DIN42802 connectors, blue wire is active
4manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Technomed Engineering B.V. |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Record published | 2017-06-28 |
| Record revised | 2025-02-17 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelfbox of 10, shelfbox, pouch, pack of 20, shelfbox of 5, shelfbox of 20 |
| Sizes | Length 14 to 20 mm; needle gauge 27 to 30 G; outer diameter 0.3 to 0.38 mm; lumen/inner diameter 0.38 mm |
| Distribution end date | 2023-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3601-00-TE | In distribution | |
| 4015-00 | In distribution | |
| 4056-00 | In distribution | |
| 5888-00 | In distribution | |
| 5886-00 | In distribution | |
| 3605-00-TE | In distribution | |
| 4003-00 | In distribution | |
| 5885-00 | In distribution | |
| 3604-00-TE | In distribution | |
| 5887-00 | In distribution | |
| 1699-00-TE | Length 20 mm | In distribution |
| 4008-00 | In distribution | |
| 5873-00 | In distribution | |
| 4472-00 | Needle Gauge 27 G | In distribution |
| 5881-00 | Length 14 mm | In distribution |
| 4469-00 | Length 14 mm | In distribution |
| 4009-00 | In distribution | |
| 5883-00 | Needle Gauge 27 G | In distribution |
| 3600-00-TE | In distribution | |
| 5884-00 | In distribution | |
| 1699-01 | Length 20 mm | In distribution |
| 3603-00-TE | In distribution | |
| 4013-00 | In distribution | |
| 4006-00 | In distribution | |
| 5872-00 | Length 14 mm | In distribution |
| 5248-00 | In distribution | |
| BTP255-2.3-1B | In distribution | |
| 5874-00 | In distribution | |
| 3602-00-TE | In distribution | |
| 4024-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 204 |
| Technomed Europe | Technomed Engineering B.V. | 114 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 66 |
| Friendship Medical | Xi’an Friendship Medical Electronics Co., Ltd. | 66 |
| Cadwell | Technomed Engineering B.V. | 61 |
| The Electrode Store | Impulse Technology LLC | 56 |
| Horizon™ | LifeSync Corporation | 55 |
| Rochester | Rochester Electro Medical, Inc. | 41 |
| Temena | Temena GmbH | 34 |
| Cadwell | Xi’an Friendship Medical Electronics Co., Ltd. | 33 |
Showing 12 of 106. All products under Electrode, Needle
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Technomed Europe | UDI-DI | 2024-07-25 | Class II | Process control | Product has have presence of brown discoloration or substance on the hinge area of the device | 71 units |
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.