Primary Device ID | 00858290006154 |
NIH Device Record Key | 28856b3c-a5d4-40ad-8843-1911350c3aff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FluoriMax 2.5% NaF Varnish Flow Through |
Version Model Number | 530BGV101 |
Company DUNS | 002863526 |
Company Name | ELEVATE ORAL CARE, LLC |
Device Count | 1 |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |