| Primary Device ID | 04260166371758 |
| NIH Device Record Key | 66bfc960-6f00-4959-80e0-9d11b4ac8589 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartAblateTM System |
| Version Model Number | M490006 |
| Company DUNS | 327536314 |
| Company Name | Stockert GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | true |
| OTC Over-The-Counter | false |