| Primary Device ID | 00196527447258 |
| NIH Device Record Key | 91b9daa9-eab3-4566-be88-a6ad99a67eef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zenlens Patient Kit |
| Version Model Number | ZPK8 |
| Catalog Number | ZPK8 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00196527447258 [Primary] |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-25 |
| Device Publish Date | 2025-06-17 |
| 00196527447258 - Zenlens Patient Kit | 2025-06-25Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit |
| 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 |