| Primary Device ID | EBRE540002119 |
| NIH Device Record Key | 339b546b-8c5b-40a7-976d-995e2209b884 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pi-Ku-Plast HP 36 monomer, |
| Version Model Number | 54000211 |
| Catalog Number | 54000211 |
| Company DUNS | 341086190 |
| Company Name | bredent GmbH & Co. KG |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |