| Primary Device ID | 10348783015574 |
| NIH Device Record Key | 0629cd71-9a5b-4796-ae6e-fd7e622ff014 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynex Lugols |
| Version Model Number | 9045066 |
| 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 | 00348783015577 [Primary] |
| GS1 | 10348783015574 [Package] Contains: 00348783015577 Package: case [20 Units] In Commercial Distribution |
| IAM | Solution, Lugol'S |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-11 |
| Device Publish Date | 2026-02-03 |
| 00348783004069 - Premier Elevator | 2026-03-25 ELEVATOR 303 B |
| 00348783004076 - Premier Elevator | 2026-03-25 ELEVATOR 304 B |
| 00348783004182 - Premier Elevator | 2026-03-25 ELEVATOR 80 |
| 00348783004229 - Premier Elevator | 2026-03-25 ELEVATOR HEIDBRINK 13-14 |
| 00348783005929 - Premier Explorers | 2026-03-25 CAVITY FINDER DE TU 17/23 |
| 00348783005974 - Premier Explorers | 2026-03-25 CAVITY FINDER SE 23 |
| 00348783005998 - Premier Explorers | 2026-03-25 CAVITY FINDER DE 5 |
| 00348783006018 - Premier Explorers | 2026-03-25 CAVITY FINDER DE 6/23 |