Ultra High Copper Spherical 099-55047

GUDID D033099550471

Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam
Primary Device IDD033099550471
NIH Device Record Key65e8c66f-e7ac-417a-a2f0-1f11da0f7d8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra High Copper Spherical
Version Model Number55047
Catalog Number099-55047
Company DUNS106792427
Company NameDMG AMERICA, LLC
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com

Device Dimensions

Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram
Weight800 Milligram

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD033099550470 [Unit of Use]
HIBCCD033099550471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, Amalgam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-09-19
Device Publish Date2016-09-23

On-Brand Devices [Ultra High Copper Spherical]

D033099550671Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 500 jar
D033099550661Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D033099550651Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D033099550471Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D033099550461Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D033099550451Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 50 jar

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