| Primary Device ID | 08800016905182 |
| NIH Device Record Key | b2c955a8-ad55-4d36-beda-a3aedbd7164a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUADESSY Neutral hand piece |
| Version Model Number | QD1-M400 |
| Company DUNS | 689842183 |
| Company Name | CLASSYS 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |