| Primary Device ID | 27630055502944 |
| NIH Device Record Key | e54f6bb5-2519-4329-9211-b8eebd3ead61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bur PM2-95 80K Diam Ø3.1 St |
| Version Model Number | 1100323 |
| Catalog Number | 1100323-001 |
| Company DUNS | 481597719 |
| Company Name | Bien-Air Surgery SA |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |