N/A
- Primary DI
- EINO5326379
- Brand
- N/A
- Company
- inomed Medizintechnik GmbH
- Model
- 532637
- Device description
- SDN electrodes Trigon RD/BK15 mm/2 m, 10 pcs.
- Published
- 2016-08-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| ETN | Stimulator, Nerve |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EINO5326379 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Subdermal needle electrode | A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device. |
Regulatory Flags
- DUNS number
- 340782259
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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