| Primary Device ID | ENOU1784NOU9 |
| NIH Device Record Key | 4b51b5c8-cf44-4d34-b675-3aefeafa75ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinal burr tungsten carbide round 4.0mm |
| Version Model Number | 1784NOU |
| 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 | ENOU1784NOU0 [Unit of Use] |
| HIBCC | ENOU1784NOU9 [Primary] |
| GEY | Motor, Surgical Instrument, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[ENOU1784NOU9]
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 |
| ENOU4161US0 - Dispenser DP 30 LipoPlus | 2023-09-27 Infiltration pump, SET |
| ENOU4163US0 - Dispenser DP 30 LipoPlus | 2023-09-27 Infiltration pump, SET |
| ENOU4180US0 - Dispenser DP 30 | 2023-09-27 Infiltration pump |
| ENOU4181US0 - Dispenser DP 30 LipoPlus | 2023-09-27 Infiltration pump |
| ENOU4186US0 - Dispenser DP 30 | 2023-09-27 Infiltration pump |
| ENOU4187US0 - Dispenser DP 30 | 2023-09-27 Infiltration pump, SET |
| ENOU4052USA9 - Suction jar 2L | 2021-12-22 scaled suction jar 2L with lid, sterilizable |
| ENOU4245USA9 - Suction jar 4L | 2021-12-22 scaled suction jar 4L with lid, sterilizable |