Neuroline MonopolarNeurology Needle Electrodes
10 catalogue numbers from 74325-36/40, listed by Ambu A/S, Denmark, under Electrode, Needle. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
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 | Ambu A/S, Denmark |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Establishment | Specification developer, Private-label distributor, Manufacturer, Exporter |
| Record published | 2016-09-22 |
| Record revised | 2026-01-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 10 to 25 °C; Storage environment temperature 10 to 25 °C |
| Packaging | Pack of 8, pack of 40 |
| Sizes | Lumen/inner diameter 0.36 to 0.5 mm; length 25 to 75 cm; length 25 to 75 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 74325-36/40 | Lumen/Inner Diameter 0.36 mm | In distribution |
| 74375-50/40 | Lumen/Inner Diameter 0.5 mm | In distribution |
| 74350-45/40 | Lumen/Inner Diameter 0.45 mm | In distribution |
| 74238-45/40 | Lumen/Inner Diameter 0.45 mm | In distribution |
| 74225-36/40 | Lumen/Inner Diameter 0.36 mm | In distribution |
| 74250-45/40 | Lumen/Inner Diameter 0.45 mm | In distribution |
| 74338-36/40 | Length 38 cm | In distribution |
| 74238-36/40 | Length 38 mm | In distribution |
| 74338-45/40 | Length 38 cm | In distribution |
| 74275-50/40 | Length 75 mm | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071185 | 2007-05-30 |
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.