| Primary Device ID | 03664188000428 |
| NIH Device Record Key | dca0b905-b509-4446-980d-e43d57cd82ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Carl Zeiss Meditec |
| Version Model Number | Velara 200 |
| Company DUNS | 260432380 |
| Company Name | LUNEAU TECHNOLOGY OPERATIONS |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03664188000428 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| 03664188000411 - Visionix | 2024-05-08 |
| 03664188000084 - Visionix | 2023-06-23 |
| 03664188000008 - Visionix | 2023-06-16 ophthalmic slit lamp |
| 03664188000015 - Visionix | 2023-06-16 ophthalmic slit lamp |
| 03664188000060 - Visionix | 2023-06-16 The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, and pachymeter, indicated for |
| 03664188000091 - Visionix | 2023-06-16 ophthalmic slit lamp |
| 03664188000114 - Luneau | 2023-06-16 The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a f |
| 03664188000145 - Visionix VX650 | 2023-06-16 |