| Primary Device ID | 00856596006403 |
| NIH Device Record Key | f24a082a-206f-47ee-8c32-9d3364b9e5e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CariFree Fluoride Varnish |
| Version Model Number | Mint |
| Company DUNS | 195544965 |
| Company Name | Dental Alliance Holdings 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856596006403 [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 | 2022-02-18 |
| Device Publish Date | 2022-02-10 |
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| 00856596006403 | A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for |