VARI-STIM®
- Primary DI
- 20643169341818
- Brand
- VARI-STIM®
- Company
- MEDTRONIC XOMED, INC.
- Model
- 8562010
- Device description
- STIMULATOR 8562010 VARI-STIM 10PK ROHS
- Published
- 2016-04-22
- 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 |
|---|
| 20643169341818 | Package | GS1 | 10 | In Commercial Distribution |
| 00643169341814 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 20643169341818 | 20643169341818 | | |
| 00643169341814 | 00643169341814 | 643169341814 | 0643169341814 |
GMDN Terms
| Term | Definition |
|---|
| Nerve-locating system | An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -40 Degrees Celsius | 70 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 835465063
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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