| Primary Device ID | 10816744028159 |
| NIH Device Record Key | 03e16b43-47cf-475f-a589-b7b1a13b7878 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NICO Fluid System |
| Version Model Number | NN-8015 |
| Company DUNS | 829838288 |
| Company Name | NICO CORPORATION |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 317-660-7118 |
| info@NICOneuro.com | |
| Phone | 317-660-7118 |
| info@NICOneuro.com | |
| Phone | 317-660-7118 |
| info@NICOneuro.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816744028152 [Primary] |
| GS1 | 10816744028159 [Package] Contains: 00816744028152 Package: [5 Units] In Commercial Distribution |
| KYZ | Syringe, Irrigating (Non Dental) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-12 |
| Device Publish Date | 2016-09-14 |
| 00816744027230 - Myriad-LX | 2025-08-19 |
| 00816744020118 - NICO Myriad | 2025-08-07 Illumination Pack - 11 Gauge x 10 cm |
| 00816744021139 - NICO Myriad | 2025-08-07 Illumination Pack - 11 Gauge x 13 cm |
| 00816744021313 - NICO Myriad | 2025-08-07 Illumination Pack - 13 Gauge x 10am |
| 00816744021337 - NICO Myriad | 2025-08-07 Illumination Pack - 13 Gauge x 13 cm |
| 00816744024031 - NICO Myriad | 2025-08-07 Handpiece + Illumination Pack 13GA x 10cm |
| 00816744024048 - NICO Myriad | 2025-08-07 Handpiece + Illumination Pack 13GA x 13cm |
| 00816744024062 - NICO Myriad | 2025-08-07 Handpiece + Illumination Pack 11GA x 10cm |