| Primary Device ID | ENOU1045NOU0 |
| NIH Device Record Key | b24a5d73-c657-48fe-9447-41fe1e3ff343 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Handpiece for MIS spinal surgery burrs |
| Version Model Number | 1045NOU |
| Company DUNS | 480610476 |
| Company Name | Nouvag AG |
| 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 | 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 | ENOU1045NOU0 [Primary] |
| GEY | Motor, Surgical Instrument, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[ENOU1045NOU0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-08-21 |
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