| Primary Device ID | 03661540304415 |
| NIH Device Record Key | 53a5faa4-0f74-4a6d-92a9-22ad2039e52e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excyte 20 |
| Version Model Number | 20 (8 mm) |
| Catalog Number | EX-10318 |
| Company DUNS | 052423787 |
| Company Name | ELITECHGROUP 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 | false |
| Serial Number | true |
| 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 |