| Primary Device ID | 03760243000553 |
| NIH Device Record Key | f1dc2d5a-1bbb-4382-a06e-eedb2889ae05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Total protec by RISKONTROL |
| Version Model Number | RISKONTROL |
| Catalog Number | 201751 |
| Company DUNS | 277657631 |
| Company Name | PRODUITS DENTAIRES PIERRE ROLLAN |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |