SonicOne Clinic
- Primary DI
- 00841626100992
- Brand
- SonicOne Clinic
- Company
- MISONIX, INC.
- Model
- E-SOP-HP
- Device description
- SonicOne Clinic Handpiece
- 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 |
|---|
| 00841626100992 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841626100992 | 00841626100992 | 841626100992 | 0841626100992 |
GMDN Terms
| Term | Definition |
|---|
| Hard-tissue ultrasonic surgical system handpiece | A hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current into an ultrasonic oscillation, and transfer the energy to an attachable tip, to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. The handpiece typically includes cables for power supply and tubing to circulate cooling fluid to the attachable tip. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
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
- true
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