| Primary Device ID | 00850358007097 |
| NIH Device Record Key | 2cc8f6d1-d9ff-4de2-b942-93fe67c1b40c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Impoaid |
| Version Model Number | Ring Kit |
| Catalog Number | 44023-001 |
| Company DUNS | 614647725 |
| Company Name | ENCORE, INC. |
| 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 | true |