| Primary Device ID | EDMG2203850 |
| NIH Device Record Key | 88da731d-1c42-4bc2-8a48-1bec378712f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Icon-Etch Refill |
| Version Model Number | 220385 |
| Catalog Number | 220385 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 1 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *After use, dispose of the product in household waste. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG2203850 [Primary] |
| HIBCC | EDMG2203851 [Package] Package: [3 Units] In Commercial Distribution |
| EBC | Sealant, Pit And Fissure, And Conditioner |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-09 |
| Device Publish Date | 2019-07-01 |
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