| Primary Device ID | 00785811435721 |
| NIH Device Record Key | 9a2610e9-834a-4ced-9c66-fbc60cd2d6b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boston II |
| Version Model Number | itafocon A |
| Catalog Number | Boston II |
| Company DUNS | 058816302 |
| 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 | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00785811435721 [Primary] |
| HQD | Lens, Contact (Other Material) - Daily |
| 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 | 2017-12-13 |
| 00196527447258 - Zenlens Patient Kit | 2025-06-25 Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit |
| 00757770404155 - Bausch + Lomb | 2025-06-11 CLAMP OSSICLE HOLDING SHEEHY |
| 00757770411610 - Bausch + Lomb | 2025-06-11 FCP INCUS WIRE CLOSURE MCGEE |
| 00757770413027 - Bausch + Lomb | 2025-06-11 SCISSORS BELLUCCI |
| 00757770414543 - Bausch + Lomb | 2025-06-11 SCS ALG HOUSE-BELLUCCI CVD LT |
| 00757770421428 - Bausch + Lomb | 2025-06-11 SCS ALLIGATOR HOUSE BELLUCCI |
| 00757770425969 - Bausch + Lomb | 2025-06-11 SCS ALG HOUSE-BELLUCCI CVD RT |
| 00757770426928 - Bausch + Lomb | 2025-06-11 SCISSORS BELLUCCI CURVED LEFT |