| Primary Device ID | 00858290006277 |
| NIH Device Record Key | 543bfe01-e1f9-40b5-8f64-194fe940e25a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elevate Tongue Cleaner Metal |
| Version Model Number | 655METAL0 |
| Company DUNS | 002863526 |
| Company Name | ELEVATE ORAL CARE, LLC |
| 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 | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858290006277 [Primary] |
| LCN | Scraper, Tongue |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-25 |
| Device Publish Date | 2019-01-23 |
| 00858290006895 - Povi-One | 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk |
| 00858290006888 - Advantage Arrest | 2023-07-31 Advantage Arrest, Convenience Kit |
| 00858290006871 - Allday Spray/Gel Sample Bag | 2023-05-26 Dry Mouth Spray and Gel, Mint, 1.5oz Bottle and Tube, Sample Bag |
| 00858290006758 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum |
| 00858290006765 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint |
| 00858290006772 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel |
| 00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored |
| 00858290006796 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy |