| Primary Device ID | 00380657517619 |
| NIH Device Record Key | 53996700-9a83-432e-b9df-34f2a7e22166 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Centurion, OZil |
| Version Model Number | 8065751761 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380657517619 [Primary] |
| HQE | Instrument, vitreous aspiration and cutting, ac-powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00380657517619]
Moist Heat or Steam Sterilization
[00380657517619]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-06 |
| 00380650005656 - Centurion | 2024-08-02 Centurion Vision System With Active Sentry without IV Pole |
| 10380650002362 - UNITY TETRASPOT | 2024-07-11 25GA TETRASPOT MultiSpot Laser Probe |
| 10380650002379 - UNITY TETRASPOT | 2024-07-11 27GA TETRASPOT MultiSpot Laser Probe |
| 00380650002433 - UNITY | 2024-07-11 LASER KIT |
| 10380650002515 - ALCON | 2024-07-11 27GA Illuminated Flexible Curved Laser Probe |
| 00380650002969 - UNITY | 2024-07-11 UNITY VCS System (Anterior/Posterior) |
| 10380650003390 - UNITY | 2024-07-11 UNITY Cataract FMS Pack, 30° Balanced Tip with Ultra Infusion Sleeves |
| 10380650003406 - UNITY | 2024-07-11 UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves |