| Primary Device ID | 00348783003789 |
| NIH Device Record Key | a952ae17-3445-4212-9d50-a3c34a0ae6c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brite Shield |
| Version Model Number | 8101100 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | true |
| 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 | 00348783003789 [Primary] |
| FLG | Cleaner, Ultrasonic, Medical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-14 |
| Device Publish Date | 2024-06-06 |
| D6919011997 | Brite Shield 10 Pack |
| D6919011996 | BRITE SHIELD SAMPLE (1pk) |
| D6919011950 | CLEANER SAMPLE PACK (BS/VA) |
| D6919011911 | Brite Shield Sample INTL w/Illustration Card |
| D6919011100 | BRITE SHIELD (CASE OF 6) |
| 00348783003789 | BRITE SHIELD (Single Jar) |
| 00348783003819 | CLEANER SAMPLE PACK (BS/VA) |
| 00348783003802 | Brite Shield Sample INTL w/Illustration Card |
| 00348783003796 | BRITE SHIELD (CASE OF 6) |
| 00348783000672 | BRITE SHIELD SAMPLE (1pk) |