| Primary Device ID | 00380657530410 |
| NIH Device Record Key | bb4c5526-d807-4165-8954-765fd80acd81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONSTELLATION |
| Version Model Number | 8065753041 |
| 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 | 00380657530410 [Primary] |
| HQE | Instrument, vitreous aspiration and cutting, ac-powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-16 |
| Device Publish Date | 2018-10-16 |
| 00380657530410 | CONSTELLATION TABLE TOP |
| 00380657525379 | CONSTELLATION CR4 UPGRADE KIT |
| 10380657518859 | Constellation Vision System Basic Combined Procedure Pak |
| 00380657515417 | TRAY ARM SUPPORT COLUMN |
| 00380657515400 | BALLAST |
| 00380657515394 | TRAY ARM ASSEMBLY |
| 10380657515148 | Constellation Vision System Basic Vitrectomy Pak |
| 00380657514526 | CONSTELLATION AUXILIARY ILLUMINATOR |
| 00380657514519 | CONSTELLATION BASE |
| 00380657514502 | CONSTELLATION EMBEDDED LASER |
| 10380657511638 | Constellation Vision System Tray Arm Cover |
| 10380657511584 | Constellation Vision System 1.1 mm Tipless Phaco Pak |
| 10380657511553 | Constellation Vision System 0.9 mm Tipless Phaco Pak |
| 00380657511501 | CONSTELLATION TABLE TOP |
| 00380657509775 | CONSTELLATION FOOTSWITCH |
| 00380657509683 | CONSTELLATION REMOTE CONTROL |
| 10380657509581 | 20 GA Fragmentation Pak |
| 10380657509574 | Viscous Fluid Control Pak |
| 10380657509208 | Constellation Vision System GFI Admin Tubing Set |
| 10380657509185 | Constellation Vision System Irrigation/Aspiration Tubing Set |
| 10380657509178 | Constellation Vision System Auxiliary Aspiration Tubing |
| 10380657509147 | Constellation Vision System Infusion Tubing Set w/ AIV |
| 00380657508884 | Constellation Handpiece |
| 10380657521514 | 25GA Infustion Cannula w/ Tray |
| 10380657521491 | 23GA Infustion Cannula w/ Tray |