Primary Device ID | 04961333254309 |
NIH Device Record Key | d035b4fc-4223-4ba5-9c76-4cc020b6a8f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MULTI-SPEECH |
Version Model Number | 3706-1 |
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 |