| Primary Device ID | 10884521812185 |
| NIH Device Record Key | 99b9c90e-1266-4ec8-ba5b-1d2a9c105b43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VS3 Iridium Fluorescence Vision System 785 110V- INS configuration - ELO |
| Version Model Number | VS3-IR |
| Catalog Number | 143-0051 |
| Company DUNS | 532199478 |
| Company Name | VISIONSENSE LTD. |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521812185 [Primary] |
| GWG | Endoscope, Neurological |
| OWN | Confocal Optical Imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-09 |
| Device Publish Date | 2021-04-01 |
| 10884521842489 - VS3 Visionsense Camera Control Unit (CCU) | 2023-03-21 |
| 10813040013636 - VS3 Iridium | 2022-07-13 VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV |
| 10813040013858 - VS3 Iridium | 2022-07-13 VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View |
| 10884521833173 - VS3 Visionsense Camera Control Unit (CCU) | 2022-05-18 |
| 10884521834644 - VS3 Iridium - Laser Light Source (LLS) | 2022-05-17 |
| 10884521834651 - VS3 Iridium - Laser Light Source, 785nm (LLS) | 2022-05-17 |
| 10813040013988 - VS3 Iridium - Fluorescence High Definition Camera (Camera-IR) | 2021-08-18 |
| 10813040013995 - VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR) | 2021-08-18 |