| Primary Device ID | 10380657530684 |
| NIH Device Record Key | ba8f4707-0446-438b-850a-5b61f740cedc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIPURE & UNIPEXY |
| Version Model Number | 8065753068 |
| Catalog Number | 8065753068 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380657530687 [Primary] |
| GS1 | 10380657530684 [Package] Contains: 00380657530687 Package: Box [10 Units] In Commercial Distribution |
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-05 |
| Device Publish Date | 2024-10-28 |
| 10380657530691 | UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System i |
| 10380657530684 | UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System |