| Primary Device ID | J00716007680 |
| NIH Device Record Key | 509ca1f3-d558-426f-bffa-87d3dd759098 |
| Commercial Distribution Discontinuation | 2023-02-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PM2-A95 |
| Version Model Number | 1600768 |
| Catalog Number | 1600768-001 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J00716007680 [Direct Marking] |
| HIBCC | J00716007680011 [Primary] |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
[J00716007680]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2019-01-07 |
| J00716007680 | 1600768 |
| 17630055505702 | 1600768 |