enVista Envy™ Toric IOL ETNU300+085
GUDID 10757770642905
enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +8.50D SE / +3.00D CYL
Bausch & Lomb Incorporated
Posterior-chamber intraocular lens, pseudophakic| Primary Device ID | 10757770642905 |
| NIH Device Record Key | ec5167dc-9ee7-4a2a-be3f-f8200b80280b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | enVista Envy™ Toric IOL |
| Version Model Number | ETN |
| Catalog Number | ETNU300+085 |
| Company DUNS | 196603781 |
| Company Name | Bausch & Lomb Incorporated |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10757770642905 [Primary] |
FDA Product Code
| MFK | Lens, Multifocal Intraocular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-24 |
| Device Publish Date | 2024-10-16 |
On-Brand Devices [enVista Envy™ Toric IOL]
| 10757770644992 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +25.50D SE / +5.00D CYL |
| 10757770644985 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +25.00D SE / +5.00D CYL |
| 10757770644978 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +24.50D SE / +5.00D CYL |
| 10757770644961 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +24.00D SE / +5.00D CYL |
| 10757770644954 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +23.50D SE / +5.00D CYL |
| 10757770644947 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +23.00D SE / +5.00D CYL |
| 10757770644930 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +22.50D SE / +5.00D CYL |
| 10757770644923 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +22.00D SE / +5.00D CYL |
| 10757770644916 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +21.50D SE / +5.00D CYL |
| 10757770644909 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +21.00D SE / +5.00D CYL |
| 10757770644893 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +20.50D SE / +5.00D CYL |
| 10757770644886 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +20.00D SE / +5.00D CYL |
| 10757770644879 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +19.50D SE / +5.00D CYL |
| 10757770644862 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +19.00D SE / +5.00D CYL |
| 10757770644855 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +18.50D SE / +5.00D CYL |
| 10757770644848 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +18.00D SE / +5.00D CYL |
| 10757770644831 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +17.50D SE / +5.00D CYL |
| 10757770644824 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +17.00D SE / +5.00D CYL |
| 10757770644817 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +16.50D SE / +5.00D CYL |
| 10757770644800 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +16.00D SE / +5.00D CYL |
| 10757770644794 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +15.50D SE / +5.00D CYL |
| 10757770644787 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +15.00D SE / +5.00D CYL |
| 10757770644770 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +14.50D SE / +5.00D CYL |
| 10757770644763 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +14.00D SE / +5.00D CYL |
| 10757770644756 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +13.50D SE / +5.00D CYL |
| 10757770644749 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +13.00D SE / +5.00D CYL |
| 10757770644732 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +12.50D SE / +5.00D CYL |
| 10757770644725 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +12.00D SE / +5.00D CYL |
| 10757770644718 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +11.50D SE / +5.00D CYL |
| 10757770644701 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +11.00D SE / +5.00D CYL |
| 10757770644695 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +10.50D SE / +5.00D CYL |
| 10757770644688 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +10.00D SE / +5.00D CYL |
| 10757770644671 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +9.50D SE / +5.00D CYL |
| 10757770644664 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +9.00D SE / +5.00D CYL |
| 10757770644657 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +8.50D SE / +5.00D CYL |
| 10757770644640 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +8.00D SE / +5.00D CYL |
| 10757770644633 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +7.50D SE / +5.00D CYL |
| 10757770644626 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +7.00D SE / +5.00D CYL |
| 10757770644619 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +6.50D SE / +5.00D CYL |
| 10757770644602 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +6.00D SE / +5.00D CYL |
| 10757770644558 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +34.00D SE / +4.25D CYL |
| 10757770644541 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +33.50D SE / +4.25D CYL |
| 10757770644534 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +33.00D SE / +4.25D CYL |
| 10757770644527 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +32.50D SE / +4.25D CYL |
| 10757770644510 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +32.00D SE / +4.25D CYL |
| 10757770644503 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +31.50D SE / +4.25D CYL |
| 10757770644497 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +31.00D SE / +4.25D CYL |
| 10757770644480 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +30.50D SE / +4.25D CYL |
| 10757770644473 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +30.00D SE / +4.25D CYL |
| 10757770644466 | enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +29.50D SE / +4.25D CYL |
Trademark Results [enVista Envy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENVISTA ENVY 90811258 not registered Live/Pending |
Bausch & Lomb Incorporated 2021-07-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.