| Primary Device ID | 00893872001622 |
| NIH Device Record Key | a5a37df0-492a-4c0d-8056-e1f72ce026e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTrack Advance |
| Version Model Number | iTrack-ADS |
| Catalog Number | 203000-0001 |
| Company DUNS | 079755637 |
| Company Name | Nova Eye, Inc. |
| 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 | true |
| 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 | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Catheter Working Length | 45 Millimeter |
| Outer Diameter | 250 Micrometer |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893872001622 [Primary] |
| HMX | Cannula, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-12 |
| Device Publish Date | 2023-04-04 |
| 00893872001622 - iTrack Advance | 2023-04-12Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector |
| 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 | 2020-12-08 Imaging Cap |
| 00893872001585 - ViscoInjector | 2020-12-08 Opthalmic Viscoelastic Injector |