SonicOne Clinic
- Primary DI
- 00841626100985
- Brand
- SonicOne Clinic
- Company
- MISONIX, INC.
- Model
- E-SOP-GEN
- Device description
- SonicOne Clinic Ultrasonic Surgical Aspiration System/Generator
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| LFL | Instrument, Ultrasonic Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LFL | Instrument, Ultrasonic Surgical | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00841626100985 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841626100985 | 00841626100985 | 841626100985 | 0841626100985 |
GMDN Terms
| Term | Definition |
|---|
| Ultrasonic surgical system generator | An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included. |
Regulatory Flags
- DUNS number
- 065963449
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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