| Primary Device ID | 893872001462 |
| NIH Device Record Key | aac518e9-bf29-4a60-bef4-27c2721d9fc8 |
| Commercial Distribution Discontinuation | 2017-11-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | iCAP Imaging Cap |
| Version Model Number | IC-100 |
| Catalog Number | 200549 |
| Company DUNS | 079755637 |
| Company Name | Nova Eye, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893872001028 [Primary] |
| GS1 | 893872001462 [Package] Contains: 00893872001028 Package: Multiple Unit Box [15 Units] Discontinued: 2017-11-30 Not in Commercial Distribution |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-12-08 |
| Device Publish Date | 2016-09-19 |
| 00893872001608 - iLumin | 2024-07-29 Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions |
| 00893872001622 - iTrack Advance | 2023-04-12 Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2 |
| 893872001462 - iCAP Imaging Cap | 2020-12-08Imaging Cap |
| 893872001462 - iCAP Imaging Cap | 2020-12-08 Imaging Cap |
| 00893872001585 - ViscoInjector | 2020-12-08 Opthalmic Viscoelastic Injector |