| Primary Device ID | 00192896089563 |
| NIH Device Record Key | 81a9df78-c022-4752-b932-acf77c448bd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OBTURATOR |
| Version Model Number | SPK03297 |
| Catalog Number | SPK03297 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, 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 | true |
| OTC Over-The-Counter | false |