| Primary Device ID | 00841626101296 |
| NIH Device Record Key | 9d510f56-e4a1-4434-a8c9-bc55e0de3be9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SonicOne O.R. |
| Version Model Number | MXC-BLADE-LLC |
| Company DUNS | 065963449 |
| Company Name | MISONIX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841626101296 [Primary] |
| GS1 | 10841626101293 [Package] Package: box [5 Units] In Commercial Distribution |
| LFL | Instrument, Ultrasonic Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-26 |
| Device Publish Date | 2016-09-24 |
| 10841626101453 | SonicOne O.R. Irrigation TubeSet |
| 00841626101456 | SonicOne O.R. Irrigation TubeSet |
| 00841626101968 | SharpVac Debridement Probe with Aspiration |
| 00841626101494 | SonicOne O.R. Wide Hatch Probe Kit |
| 00841626101470 | SonicOne O.R. Hatched Titanium Probe Kit |
| 00841626101432 | SonicOne O.R. Micro Bone Shaver |
| 00841626101418 | SonicOne O.R. 360 Bone Shaver |
| 00841626101395 | SonicOne O.R. Cylindrical Titanium Probe Kit |
| 00841626101371 | SonicOne O.R. Curette Style Titanium Probe Kit |
| 00841626101357 | SonicOne O.R. Extra Large Blade |
| 00841626101340 | SonicOne O.R. Debridement Probe With Aspiration |
| 00841626101333 | SonicOne O.R. Small Blade |
| 00841626101319 | SonicOne O.R. Large Blade, Serrated |
| 00841626101296 | SonicOne O.R. Large Long Curved Blade |
| 00841626100930 | SonicOne O.R.Ultrasonic Surgical Aspiration System/Generator |
| 10841626103716 | Flat Tip Clinic Housing |
| 00841626103702 | Flat Tip Clinic Probe |
| 00841626101982 | Flat Tip Handpiece Housing |