Primary Device ID | EDMG2120648 |
NIH Device Record Key | 4100a527-a4af-4869-b05c-527487e4fcc5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LuxaCore® Smartmix Dual |
Version Model Number | 212064 |
Catalog Number | 212064 |
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 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EDMG2120640 [Primary] |
HIBCC | EDMG2120641 [Package] Contains: EDMG2120640 Package: [2 Units] In Commercial Distribution |
HIBCC | EDMG2120648 [Package] Contains: EDMG2120641 Package: [12 Units] In Commercial Distribution |
EBF | Material, Tooth Shade, 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 | 2016-09-22 |
EDMG2120648 | Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ |
EDMG2120398 | Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ |
EDMG2120388 | Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUXACORE 75569945 2358634 Live/Registered |
ERNST MUHLBAUER GMBH & CO, KG 1998-10-14 |