Primary Device ID | 07908611210036 |
NIH Device Record Key | d615fe42-ae54-4e5a-8bba-c88c17dd7eee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PROMO KIT ADVANCED ROTH 0.022" |
Version Model Number | 10.10.2958 |
Company DUNS | 898330003 |
Company Name | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA |
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 | true |
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 |