Spinal Electrode Kit
6 catalogue numbers from CEDL-2PDINX-101, listed by AD-Tech Medical Instrument Corp., United States, under Stimulator, Electrical, Evoked Response. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
6catalogue 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 | AD-Tech Medical Instrument Corp., United States |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| Establishment | Manufacturer |
| 510(k) | K973454 |
| Record published | 2016-09-23 |
| Record revised | 2023-08-23 (version 4) |
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 | Special storage condition: To be stored and used within typical hospital/office room ambient temperature and humidity conditions |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CEDL-2PDINX-101 | In distribution | |
| CEDL-3PDINX-000 | In distribution | |
| CED-4PX-000 | In distribution | |
| CEDL-2PDINX-000 | In distribution | |
| CEDL-4PDINX-100 | In distribution | |
| CEDL-2PDINX-000 | In distribution |
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 |
| Stimulator, Electrical, Evoked Response | Stryker Leibinger Gmbh & Co. KG | 29 |
| Natus | Xltek | 27 |
| Isis | Inomed Medizintechnik Gmbh | 26 |
| Xltek | Xltek | 24 |
| Natus Neurology | Natus Neurology Incorporated | 20 |
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.