| Primary Device ID | 00816744027452 |
| NIH Device Record Key | 641950bd-18d0-4950-a5c4-ea0c676aaea5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NICO BrainPath |
| Version Model Number | NN-7045 |
| Company DUNS | 829838288 |
| Company Name | NICO CORPORATION |
| 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 | false |
| 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 | 317-660-7118 |
| info@NICOneuro.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816744027452 [Primary] |
| GZT | Retractor, Self-Retaining, For Neurosurgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816744027452]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-13 |
| Device Publish Date | 2019-06-05 |
| 00816744029074 | 95 mm Stylet |
| 00816744029050 | Manipulation Tool |
| 10816744028333 | Sheath 11 mm x 75 mm |
| 10816744028326 | Sheath 11 mm x 60 mm |
| 10816744028319 | Sheath 11 mm x 50 mm |
| 00816744028305 | Sheath 13.5 mm x 95 mm |
| 10816744028265 | Shepherd's Hook Budde |
| 10816744028258 | Shepherd's Hook Sugita |
| 10816744028241 | Shepherd's Hook Greenberg |
| 10816744028135 | Sheath 13.5 mm x 75 mm |
| 10816744028128 | Sheath 13.5 mm x 60 mm |
| 10816744028111 | Sheath 13.5 mm x 50 mm |
| 00816744027445 | Kit - 2X 11 mm & 13.5 mm |
| 00816744027438 | Kit - 13.5 mm x 95 mm Upgrade |
| 00816744027421 | Kit - 2X 13.5 mm |
| 00816744027414 | Kit 13.5 mm |
| 00816744027407 | Kit - 2X 11 mm |
| 00816744027391 | Kit 11 mm |
| 00816744027384 | Obturator 11 mm x 75 mm |
| 00816744027377 | Obturator 11 mm x 60 mm |
| 00816744027360 | Obturator 11 mm x 50 mm |
| 00816744027353 | Obturator 13.5 mm x 95 mm |
| 00816744027261 | Obturator 13.5 mm x 50 mm (STGold) |
| 00816744027193 | Sterilization Tray |
| 00816744027179 | Obturator 13.5 mm x 75 mm |
| 00816744027162 | Obturator 13.5 mm x 60 mm |
| 00816744027155 | Obturator 13.5 mm x 50 mm |
| 00816744027452 | Kit - 1X 11 mm & 13.5 mm |
| 00816744028428 | Select Lock Shepherd's Hook - Greenberg |
| 10816744038455 | Navigation Probe Adapter |