SonicOne Clinic
- Primary DI
- 00841626101005
- Brand
- SonicOne Clinic
- Company
- MISONIX, INC.
- Model
- E-SOP-R1
- Device description
- SonicOne Clinic Blue Cyclindrical Titanium Probe Kit (w/Wrench)
- 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
- true
- Single use
- true
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 |
|---|
| 00841626101005 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841626101005 | 00841626101005 | 841626101005 | 0841626101005 |
GMDN Terms
| Term | Definition |
|---|
| Soft-tissue ultrasonic surgical system handpiece tip, single-use | A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device. |
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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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