| Primary Device ID | 08435389824565 |
| NIH Device Record Key | ad896e26-bf7b-4116-a450-fd58dda46c37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CASTABLE; SQUARE ABUTMENT; INTERNA UNIVERSAL |
| Version Model Number | CPSPU |
| Company DUNS | 461665312 |
| Company Name | BIOTECHNOLOGY INSTITUTE SL |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |