| Primary Device ID | 00348783001259 |
| NIH Device Record Key | 72f6c0d2-3623-4dfe-8bbf-16b610be1d37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premier Acetic Acid |
| Version Model Number | 9045052 |
| 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 | 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 | 00348783001259 [Primary] |
| IGF | Solution, Formalin-Alcohol-Acetic Acid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-17 |
| Device Publish Date | 2023-05-09 |
| 00348783004717 - Coated Graves Specula | 2024-08-14 Coated Graves Specula Wide Medium |
| 00348783004724 - Coated Graves Specula | 2024-08-14 Coated Graves Specula Wide Large |
| 00348783004731 - Coated Graves Specula | 2024-08-14 Coated Graves Specula Small |
| 00348783004748 - Coated Graves Specula | 2024-08-14 Coated Graves Specula Medium |
| 00348783004755 - Coated Graves Specula | 2024-08-14 Coated Graves Specula Large |
| 00348783004762 - Lateral Retractor | 2024-08-14 Lateral Retractor with offset blades |
| 00348783004779 - Cure-Thru Clear Cervical Matrices | 2024-08-14 CURE-THRU CMF BOX OF 275 ASST |
| 00348783004786 - Cure-Thru Clear Cervical Matrices | 2024-08-14 CURE-THRU CMF BOX OF 150 719 CT |