| Primary Device ID | 17630055505603 |
| NIH Device Record Key | bb431f7d-a169-4faa-a635-c4de5a47eee4 |
| Commercial Distribution Discontinuation | 2023-07-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Oscillating Microsaw G2 |
| Version Model Number | 1600657 |
| Company DUNS | 481597719 |
| Company Name | Bien-Air Surgery SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| 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 | 07630055505606 [Primary] |
| GS1 | 17630055505603 [Package] Contains: 07630055505606 Package: [1 Units] Discontinued: 2020-03-31 Not in Commercial Distribution |
| DWI | Saw, Electrically Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
[17630055505603]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-31 |
| Device Publish Date | 2023-07-21 |
| 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 |