| Primary Device ID | D024772245 |
| NIH Device Record Key | 4339e3c0-d2b5-4c72-9e8e-7bdcc32ea80f |
| Commercial Distribution Discontinuation | 2021-05-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 100 |
| Version Model Number | 772245 |
| Catalog Number | 772245 |
| Company DUNS | 090735093 |
| Company Name | Preventech |
| Device Count | 1200 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com | |
| Phone | 704-849-2416 |
| customerservice@preventech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D024772245 [Primary] |
| HIBCC | D0247722455 [Unit of Use] |
| LBH | Varnish, Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-06-14 |
| Device Publish Date | 2016-10-05 |
| D024772105 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 ea. 0.5mL unit dose packages |
| D024772113 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 100 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box of 100 0.5mL unit dose packages |
| D024772115 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 ea. 0.5mL unit dose packages |
| D024772145 - VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 ea. 0.5mL unit dose packages |
| D024772153 - VELLAmini 5% Sodium Fluoride Varnish Caramel Box 100 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Box of 100 0.5mL unit dose packages |
| D024772155 - VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 0.5mL unit dose packages |
| D024772215 - VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 ea. 0.5mL unit dose packages |
| D024772225 - VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 35 | 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 35 ea. 0.5mL unit dose packages |