| Primary Device ID | 10380657520951 |
| NIH Device Record Key | 145f608a-2215-4d3f-8029-94a99f038026 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alcon, Infiniti, Intrepid |
| Version Model Number | 8065752095 |
| 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 | false |
| 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 |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com |
| Outer Diameter | 1.1 Millimeter |
| Outer Diameter | 1.1 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380657520954 [Primary] |
| GS1 | 10380657520951 [Package] Contains: 00380657520954 Package: Box [6 Units] In Commercial Distribution |
| HQC | Unit, phacofragmentation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-24 |
| 10380657520968 | 0.9 mm 45° Kelman® Mini-Flared ABS® Tip |
| 10380657520951 | 0.9 mm 30° Kelman® Mini-Flared ABS® Tip |
| 10380657520944 | 0.9 mm 45° OZil® 12 Mini-Flared ABS® Tip |
| 10380657520937 | 0.9 mm 30° OZil® 12 Mini-Flared ABS® Tip |
| 10380657520906 | Basic Ultrasound |
| 10380657520883 | 0.9 mm Tipless |
| 10380657520876 | 0.9 mm 45° Kelman® Mini-Flared ABS® Tip |
| 10380657520869 | 0.9 mm 30° Kelman® Mini-Flared ABS® Tip |
| 10380657520821 | Basic Ultrasound |
| 10380657517166 | 0.9mm Tipless |