| Primary Device ID | 00840828159586 |
| NIH Device Record Key | de88620d-89d1-4e84-9ba3-2fd39d754457 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEN4 DIGITAL |
| Version Model Number | 4D055U-Z104108 |
| Catalog Number | 22203 |
| Company DUNS | 796452311 |
| Company Name | CURBELL MEDICAL PRODUCTS, 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 | true |
| 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 |