| Primary Device ID | 00380657521609 |
| NIH Device Record Key | 181e7b7d-fa1c-4b1c-af56-3d67cbac9b5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infiniti |
| Version Model Number | 8065752160 |
| 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 | false |
| 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 | 00380657521609 [Primary] |
| HQE | Instrument, vitreous aspiration and cutting, ac-powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00380657521609 | Infiniti Vision System |
| 00380657504688 | Infiniti Remote control |
| 00380657504039 | Enhanced Footswitch, Infiniti |
| 10380657502933 | Infiniti Ultrasound Multipak Basic Stand Alone |
| 10380657501578 | Anterior Vitrectomy Pak: Anterior Vitrectomy Probe w/21 GA Infusion Cannula |
| 00380657501212 | Ultrasonic Handpiece |