Ultra High Copper Spherical 099-55047

GUDID D033099550471

Dental amalgam

Primary Device ID	D033099550471
NIH Device Record Key	65e8c66f-e7ac-417a-a2f0-1f11da0f7d8e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ultra High Copper Spherical
Version Model Number	55047
Catalog Number	099-55047
Company DUNS	106792427
Company Name	DMG AMERICA, LLC
Device Count	50
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	true
Lot Batch	true
Serial Number	false
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

Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	D033099550470 [Unit of Use]
HIBCC	D033099550471 [Primary]

EJJ	Alloy, Amalgam

Steralize Prior To Use	false
Device Is Sterile	false

D033099550671	Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 500 jar
D033099550661	Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D033099550651	Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D033099550471	Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D033099550461	Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D033099550451	Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 50 jar