| Primary Device ID | 04049584037152 |
| NIH Device Record Key | 2dba6d35-e40c-4414-9cd6-f3a8915f1b17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOM 6 |
| Version Model Number | 10034820 |
| Company DUNS | 317138956 |
| Company Name | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 04049584037152 [Primary] |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-22 |
| Device Publish Date | 2026-01-14 |
| 04049584035738 - BIOM 6 HD Optic Set for f=175 mm | 2026-01-22 |
| 04049584035745 - BIOM 6 HD Optic Set for f=200 mm | 2026-01-22 |
| 04049584037152 - BIOM 6 | 2026-01-22 |
| 04049584037152 - BIOM 6 | 2026-01-22 |
| 04049584037251 - Twinfield 3 | 2026-01-22 |
| 04049584034229 - GONIO ready® CL | 2025-05-19 The GONIO ready® CL (Contact Lens) is a self-stabilizing, single-use, direct gonioscopy lens used to enable bimanual surgery in |
| 04049584029447 - BIOM ready+ 175, for f=175 mm | 2024-09-19 BIOM ready+ 175, for f=175 mm |
| 04049584029454 - BIOM ready+ 200, for f=200 mm | 2024-09-19 BIOM ready+ 200, for f=200 mm |
| 04049584001450 - BK 1/W, coated, wall version, trial lens case | 2024-09-12 BK 1/W, coated, wall version, trial lens case |