| Primary Device ID | 04961333230006 |
| NIH Device Record Key | b46e0901-2779-4e7a-aabd-d7cd5658aa5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MULTI-SPEECH |
| Version Model Number | 3706 |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |