| Primary Device ID | 17630055513578 |
| NIH Device Record Key | 06287670-422c-47cd-8105-e02372664eb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bur PM2-125 80K steel Ø7.0 sterile |
| Version Model Number | 1100978 |
| Company DUNS | 481597719 |
| Company Name | Bien-Air Surgery SA |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |