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 |