Stimulator, Electrical, Evoked Response
Paired Subdermal Electrode YE, 18x2.5mm
3manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1), Guangdong (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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-12-23 |
| Record revised | 2023-07-28 (version 3) |
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, manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 85 % RH; Special storage condition: TRANSPORT: 10-90%, -20+50¿C; Storage environment temperature 4 to 35 °C |
| Packaging | Pack of 10 |
| Sizes | Length 6 to 130 mm; angle 30 to 90 °; length 4 m |
| Distribution end date | 2020-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5140-534-629 | Offset: 2.5 Millimeter | In distribution |
| 5140-533-636 | Length 15.0 mm | In distribution |
| 5140-532-722 | Angle 90.0 ° | In distribution |
| 5140-533-638 | Length 15.0 mm | In distribution |
| 5140-532-631 | Length 15.0 mm | In distribution |
| 5140-532-633 | Length 15.0 mm | In distribution |
| 5140-534-622 | Length 12.0 mm | In distribution |
| 5140-533-631 | Length 15.0 mm | In distribution |
| 5140-532-626 | Length 15.0 mm | In distribution |
| 5140-534-625 | Offset: 2.5 Millimeter | In distribution |
| 5140-534-626 | Length 18.0 mm | In distribution |
| 5140-532-625 | Length 15.0 mm | In distribution |
| 5140-534-621 | Length 12.0 mm | In distribution |
| 5140-532-720 | Length 6.0 mm | In distribution |
| 5140-533-633 | Length 15.0 mm | In distribution |
| 5140-534-627 | Offset: 2.5 Millimeter | In distribution |
| 5140-534-624 | Offset: 2.5 Millimeter | In distribution |
| 5140-532-636 | Length 15.0 mm | In distribution |
| 5140-534-620 | Length 12.0 mm | In distribution |
| 5140-532-638 | Length 15.0 mm | In distribution |
| 5140-533-625 | Length 15.0 mm | In distribution |
| 5140-520-044 | Length 4.0 m | Withdrawn |
| 5140-525-608 | Length 85.0 mm | Withdrawn |
| 5140-522-610 | Length 45.0 mm | Withdrawn |
| 5140-510-025 | Withdrawn | |
| 5140-522-603 | Angle 30.0 ° | Withdrawn |
| 5140-525-603 | Angle 30.0 ° | Withdrawn |
| 5140-522-606 | Length 130.0 mm | Withdrawn |
| 5140-540-425 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Electrical, Evoked Response | Inomed Medizintechnik Gmbh | 170 |
| Alpine BioMed | Alpine Biomed Aps | 132 |
| Natus | Natus Neurology Incorporated | 98 |
| Keypoint | Natus Manufacturing Limited | 44 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden America, Inc. | 41 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden Corp. | 38 |
| Powerease™ Instruments | Medtronic Sofamor Danek, Inc. | 36 |
| Natus | Xltek | 27 |
| Isis | Inomed Medizintechnik Gmbh | 26 |
| Xltek | Xltek | 24 |
| Natus Neurology | Natus Neurology Incorporated | 20 |
| Pulse | Nuvasive, Inc. | 16 |
Showing 12 of 121. All products under Stimulator, Electrical, Evoked Response
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.