| Primary Device ID | D832600BF4000 |
| NIH Device Record Key | c5c99a9d-257c-4653-9dd8-eb6a50f64c24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXAPPLICATOR II |
| Version Model Number | 600B-F-400 |
| Catalog Number | 600B-F-400 |
| Company DUNS | 190377184 |
| Company Name | PLASDENT CORPORATION |
| Device Count | 400 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |