| Primary Device ID | 00810131040727 |
| NIH Device Record Key | d3a50ea4-7537-41ad-b96b-0a7b9ff51e32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultim8 Sanitizer UV Blue |
| Version Model Number | 12000001 |
| Company DUNS | 049384038 |
| Company Name | Supermouth 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 | false |
| Serial Number | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810131040727 [Primary] |
| JEQ | Toothbrush, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-06-01 |
| 00810131044190 - Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush | 2025-07-08 Ultim8 Adult Rechargeable Sonic Toothbrush Blue Color with 2 brush heads |
| 00810131044725 - Adult SuperScraper Silver | 2025-07-08 Manual Tongue Cleaner Silver color |
| 00810131044732 - Adult SuperScraper Rose Gold | 2025-07-08 Manual Tongue Cleaner Rose Gold color |
| 00850036799993 - Ultim8 Sonic Pearly White Toothbrush & UV Sanitizer Box Set | 2025-07-08 Box containing the electric brush, 2 brush heads, one UV Sanitizer, charger & charger cables. |
| 00810131041502 - Adult Resuable Tongue Scraper | 2025-06-02 Stainless-Steel Tongue Scraper |
| 00810131041519 - Ortho Resuable Tongue Scraper Silver | 2025-06-02 Stainless-Steel Tongue Scraper |
| 00810131041526 - Ortho Resuable Tongue Scraper Rose Gold | 2025-06-02 Stainless-Steel Tongue Scraper |
| 00810131040000 - Super Vanilla Ortho Floss Fluoride | 2024-06-10 |