| Primary Device ID | 00380655011010 |
| NIH Device Record Key | d41d30ca-6772-46a6-9c7f-d0e7b34f9b23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eyelite, Alcon |
| Version Model Number | 8065-5011-01 |
| Company DUNS | 008018525 |
| Company Name | Alcon Laboratories, 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380655011010 [Primary] |
| HQF | Laser, ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00380659983290 - ORA System® VerifEye™ | 2025-12-09 ORA System with VerifEye + Technology, Abberometer 184.5mm Transient, non-invasive, active therapeutic device, intended for dia |
| 00380659983306 - ORA System® VerifEye™ | 2025-12-09 ORA System with VerifEye + Technology , Abberometer 195.5mm Transient, non-invasive, active therapeutic device, intended for dia |
| 00380652399616 - Clareon | 2025-12-04 CLAREON TORIC AUTONOME |
| 00380652399623 - Clareon | 2025-12-04 CLAREON TORIC AUTONOME |
| 00380652399630 - Clareon | 2025-12-04 CLAREON TORIC AUTONOME |
| 00380652399647 - Clareon | 2025-12-04 CLAREON TORIC AUTONOME |
| 00380652399654 - Clareon | 2025-12-04 CLAREON TORIC AUTONOME |
| 00380652399661 - Clareon | 2025-12-04 CLAREON TORIC AUTONOME |