| Primary Device ID | ENOU1766NOU9 |
| NIH Device Record Key | efdb1bc0-3446-45e1-92fa-6236bbbd79e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinal burr tungsten carbide round 3.5mm |
| Version Model Number | 1766NOU |
| Company DUNS | 480610476 |
| Company Name | Nouvag AG |
| Device Count | 3 |
| 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 | true |
| Serial Number | false |
| 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 |
| Phone | +41718466600 |
| info@nouvag.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | ENOU1766NOU0 [Unit of Use] |
| HIBCC | ENOU1766NOU9 [Primary] |
| GEY | Motor, Surgical Instrument, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[ENOU1766NOU9]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-29 |
| Device Publish Date | 2019-08-21 |
| ENOU1766NOU9 | Spinal burr tungsten carbide round 3.5mm |
| ENOU1765NOU9 | Spinal burr tungsten carbide round 3.5mm |
| ENOU1759NOU9 | Spinal burr tungsten carbide round 3.5mm |
| ENOU1738NOU9 | Spinal burr tungsten carbide round 3.5mm |