| Primary Device ID | EDMG2123851 |
| NIH Device Record Key | 0ca6b982-c817-4efd-8f9d-b97631146c46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endobrushes |
| Version Model Number | 212385 |
| Catalog Number | 212385 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 25 |
| 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 | true |
| 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 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG2123850 [Unit of Use] |
| HIBCC | EDMG2123851 [Primary] |
| KXR | Applicator, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-08 |
| Device Publish Date | 2022-06-30 |
| EDMG2123851 | Endobrushes Red. Suitable for LuxaBond Total-Etch. Content: 25 Brushes |
| EDMG2123860 | Endobrushes Black. Suitable for LuxaBond Total-Etch. Content: 25 Brushes |