| 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 |
| 10380657530660 - UNIPURE & UNIFEYE | 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
| 10380657530677 - UNIPURE & UNIFEYE | 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
| 10380657530684 - UNIPURE & UNIPEXY | 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
| 10380657530691 - UNIPURE & UNIPEXY | 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated r |
| 17612717072098 - FINESSE ModifEYE | 2024-10-04 25G ModifEYE Soft Tip Backflush - Long |
| 17612717072104 - FINESSE ModifEYE | 2024-10-04 27+ ModifEYE Soft Tip Backflush - Long |
| 17612717072067 - FINESSE ModifEYE | 2024-10-03 25G ModifEYE Soft Tip Backflush |
| 17612717072074 - FINESSE ModifEYE | 2024-10-03 27+ ModifEYE Soft Tip Backflush |