| Primary Device ID | 00858290006932 |
| NIH Device Record Key | 30b26f1a-4301-43de-aadd-f9d01fd37136 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Povi-One |
| Version Model Number | Povi-One/FluoriMax Varnish BG Convenience |
| Catalog Number | 640POFM80 |
| 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 |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858290006932 [Primary] |
| LBH | Varnish, Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 00858290006895 | Povi-One Unit Dose, .45ml, Demo 2pk |
| 00858290006932 | Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle |