| Primary Device ID | 04049584035738 |
| NIH Device Record Key | e574ac3c-5c21-4b53-babc-f690bd13710b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOM 6 HD Optic Set for f=175 mm |
| Version Model Number | 10029900 |
| 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049584035714 [Primary] |
| GS1 | 04049584035738 [Package] Contains: 04049584035714 Package: [4 Units] In Commercial Distribution |
| HOH | Spectacle, Operating (Loupe), 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 | 2026-01-22 |
| Device Publish Date | 2026-01-14 |
| 04049584037695 - Focusing Module BIOM 6, 175 mm | 2026-02-02 |
| 04049584037701 - Focusing Module BIOM 6, 200 mm | 2026-02-02 |
| 04049584037718 - Precision Mount for B&L | 2026-02-02 |
| 04049584037725 - Precision Mount for Leica | 2026-02-02 |
| 04049584037732 - Precision Mount for Alcon | 2026-02-02 |
| 04049584037749 - Precision Mount for Zeiss | 2026-02-02 |
| 04049584037756 - Precision Mount for Haag Streit | 2026-02-02 |
| 04049584035738 - BIOM 6 HD Optic Set for f=175 mm | 2026-01-22 |
| 04049584035738 - BIOM 6 HD Optic Set for f=175 mm | 2026-01-22 |