Bovie
- Primary DI
- 00887482176863
- Brand
- Bovie
- Company
- SYMMETRY SURGICAL INC.
- Model
- 0003Y
- Device description
- Neuro Pulse Yellow LED (10/bx)
- Published
- 2024-08-27
- Public version status
- New
- 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 |
|---|
| 00887482176863 | Package | GS1 | 10 | In Commercial Distribution |
| 10887482176853 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Facial nerve-locating system | An assembly of devices designed to locate a facial nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. It typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge, electrical sensors), and audible and/or visual indicators. The system generates rectangular- and possibly triangular-waveform currents to stimulate nerve fibres and produce muscular contraction. It is used during diagnosis and assessment of nerve function, to locate nerves during surgery reducing the chance of accidental injury, and to monitor the progress of nerve regeneration after surgery. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Humidity | 10 Percent (%) Relative Humidity | 75 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 10 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 079641356
- 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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