| Primary Device ID | EDMG2109111 |
| NIH Device Record Key | f0e4848a-c82e-4a96-9d2d-f060ec551b14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ionosit Baseliner |
| Version Model Number | 210911 |
| Catalog Number | 210911 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG2109110 [Unit of Use] |
| HIBCC | EDMG2109111 [Primary] |
| HIBCC | EDMG2109118 [Package] Package: [12 Units] In Commercial Distribution |
| EBD | Coating, Filling Material, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
| EDMG2230021 | Light-curing compomer base liner. Gap-free restorations. Content: 2 syringes @ 1.5 g paste, Acce |
| EDMG2109111 | Light-curing compomer base liner. Gap-free restorations. Content: 10 saferinges @ 0,3 g. |