| Primary Device ID | D716TNSRBGC6000400 |
| NIH Device Record Key | 536bc023-5a8b-431d-b82e-e1676d4e27db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GuttaCore Obturators |
| Version Model Number | TNSRBGC600040 |
| Catalog Number | TNSRBGC600040 |
| Company DUNS | 942778564 |
| Company Name | TULSA DENTAL PRODUCTS LLC |
| Device Count | 6 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |