| Primary Device ID | 00860003986806 |
| NIH Device Record Key | 90e97973-39cf-426f-bea7-1e1b84161ce6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENESIS BI-WING APP GEN 3.0 |
| Version Model Number | FPLS-3000 |
| Catalog Number | FPLS-3000 |
| Company DUNS | 079575412 |
| Company Name | Infinitus Medical Technologies LLC |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |