| Primary Device ID | 00788832105505 |
| NIH Device Record Key | 09e35d31-74c0-4c8e-b12e-ddf6a7076b79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XO Flo |
| Version Model Number | NA |
| Company DUNS | 948902387 |
| Company Name | GLADRAGS SUSTAINABLE WOMEN'S HEALTH, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |