| Primary Device ID | 17612717072104 |
| NIH Device Record Key | e49702c1-4d2b-41f8-aa7c-958691ece8cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FINESSE ModifEYE |
| Version Model Number | 337.68L |
| Catalog Number | 337.68L |
| Company DUNS | 008018525 |
| Company Name | Alcon Laboratories, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07612717072107 [Primary] |
| GS1 | 17612717072104 [Package] Contains: 07612717072107 Package: Box [6 Units] In Commercial Distribution |
| HMX | Cannula, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-04 |
| Device Publish Date | 2024-09-26 |
| 17612717072074 | 27+ ModifEYE Soft Tip Backflush |
| 17612717072067 | 25G ModifEYE Soft Tip Backflush |
| 17612717072104 | 27+ ModifEYE Soft Tip Backflush - Long |
| 17612717072098 | 25G ModifEYE Soft Tip Backflush - Long |