| Primary Device ID | J01854580 |
| NIH Device Record Key | 6ecbc29d-9b9b-4311-bcb9-704eafa40732 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IST® Appliance |
| Version Model Number | 5458.1 |
| Company DUNS | 317683787 |
| Company Name | Scheu-Dental GmbH |
| Device Count | 4 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |