| Primary Device ID | 27630055507468 |
| NIH Device Record Key | 572f7ed8-39ca-4b4c-bea9-4bafdfeb6b79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HS Craniotome Burr, short, 80k |
| Version Model Number | 362640 S |
| Catalog Number | 1100605-001 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17630055507461 [Primary] |
| GS1 | 27630055507468 [Package] Contains: 17630055507461 Package: Box [1 Units] In Commercial Distribution |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-02 |
| Device Publish Date | 2023-02-22 |
| 07630055508072 - PM2-S MIS | 2025-03-31 |
| 17630055508093 - PM2-Nose MIS D150 | 2025-03-31 |
| 17630055512601 - PM2-Nose MIS P160 | 2025-03-31 |
| 17630055506266 - Bur PM2-MIS D150 steel Ø2.0 St | 2025-03-31 |
| 17630055506273 - Bur PM2-MIS D150 steel Ø3.0 St | 2025-03-31 |
| 17630055506280 - Bur PM2-MIS D150 diam Ø2.0 St | 2025-03-31 |
| 17630055506297 - Bur PM2-MIS D150 diam Ø3.0 St | 2025-03-31 |
| 17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St | 2025-03-31 |