| Primary Device ID | EDMG9898308 |
| NIH Device Record Key | afdedd40-82c4-4f03-8a48-5e5470faad6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Honigum Pro Mono |
| Version Model Number | 989830 |
| Catalog Number | 989830 |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG9898300 [Primary] |
| HIBCC | EDMG9898301 [Package] Contains: EDMG9898300 Package: [4 Units] In Commercial Distribution |
| HIBCC | EDMG9898308 [Package] Contains: EDMG9898301 Package: [6 Units] In Commercial Distribution |
| ELW | Material, Impression |
| 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 | 2016-09-22 |
| EDMG9898308 | Impression material, medium-bodied consistency. Impression made your way. Content: 4 cartridges |
| EDMG9895688 | Impression material, medium-bodied consistency. Impressions made your way. Content: 1 cartridge |