Neuroguard
Disposable Subdermal Needle Electrode, twisted, Stainless Steel, 4 x 6 colors, 2.5m PVC twisted wire
2manufacturers in China registered for this device type
11catalogue 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 | Technomed Engineering B.V. |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Record published | 2023-01-02 |
| Record revised | 2025-02-17 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Shelf box of 24, shelf box of 8, shelfbox of 12, shelf box of 12, shelfbox of 24, shelfbox of 10 |
| Sizes | Outer diameter 0.3 to 0.6 mm; length 14 to 22 mm; needle gauge 23 to 30 G; length 1.2 to 1.5 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S50715-004-C | Length 1.5 m | In distribution |
| S22-937 | Needle Gauge 30 G | In distribution |
| S23-937 | Needle Gauge 30 G | In distribution |
| S23-837 | Needle Gauge 30 G | In distribution |
| S50715-001-C | Needle Gauge 23 G | In distribution |
| S22-837 | Needle Gauge 30 G | In distribution |
| S42-937/02 | Outer Diameter 0.38 mm | In distribution |
| S41-438 | Outer Diameter 0.38 mm | In distribution |
| S46-837 | Outer Diameter 0.38 mm | In distribution |
| S42-937 | Outer Diameter 0.38 mm | In distribution |
| S42-637 | Outer Diameter 0.38 mm | 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 |
| Bionen | Bionen SAS DI Barbara Nencioni & C. | 17 |
| Natus Neurology | Natus Neurology Incorporated | 13 |
| 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.