| Primary Device ID | 17630055505672 | 
| NIH Device Record Key | e8764e45-b2d5-4e05-b029-bd9759b951d5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PM2-A70 | 
| Version Model Number | 1600765 | 
| Catalog Number | 1600765-001 | 
| 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 | true | 
| 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 | 
|---|---|
| GS1 | 07630055505675 [Primary] | 
| GS1 | 17630055505672 [Package] Contains: 07630055505675 Package: [1 Units] In Commercial Distribution | 
| HIBCC | J00716007650011 [Previous] | 
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
[17630055505672]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-02-17 | 
| Device Publish Date | 2023-02-09 | 
| J00716007650 | 1600765 | 
| 17630055505672 | 1600765 |