| Primary Device ID | 10380657510020 |
| NIH Device Record Key | 13c50d26-fd86-4b35-8c8f-4b92e840e265 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Engauge |
| Version Model Number | 8065751002 |
| 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 | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)862-5266 |
| web.masterus@alcon.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380657510023 [Primary] |
| GS1 | 10380657510020 [Package] Contains: 00380657510023 Package: Box [12 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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 10380657517050 | 25+® Short Endoilluminator |
| 10380657517012 | 27+® Endoilluminator |
| 10380657515773 | 25 GA Chandelier |
| 10380657515766 | 23 GA Pik Endoilluminator |
| 10380657515728 | 25 GA Pik Endoilluminator |
| 10380657514868 | 25+® Wide Angle Endoilluminator |
| 10380657514417 | 25+® Endoilluminator |
| 10380657511850 | 25 GA Wide Angle Endoilluminator |
| 10380657511843 | 23 GA Wide Angle Endoilluminator |
| 10380657510037 | 20 GA Shielded Bullet Pik Endoilluminator |
| 10380657510020 | 20 GA Pik Endoilluminator |
| 10380657510013 | 20 GA End Irrg Endoilluminator |
| 00380657509836 | 20 Ga Straight Illuminated Laser Probe with engauge RFID |
| 00380657509829 | 20 Ga Curved Illuminated Laser Probe with engauge RFID |
| 10380657509765 | 25 GA Endoilluminator |
| 10380657509758 | 20 GA Wide Angle Endoilluminator |
| 10380657509741 | 20 GA Bullet Endoilluminator |
| 10380657509734 | 20 GA Shielded Bullet Endoilluminator |
| 10380657509727 | 23 GA Endoilluminator |
| 10380657509710 | 20 GA Endoilluminator |