EdgeOne Fire™ MEOFMEDGP

GUDID 10818365020604

Synthetic gutta-percha

Primary Device ID	10818365020604
NIH Device Record Key	a90ef896-b889-4a9b-a58c-39a3ffb8f3a5
Commercial Distribution Status	In Commercial Distribution
Brand Name	EdgeOne Fire™
Version Model Number	MEOFMEDGP
Catalog Number	MEOFMEDGP
Company DUNS	061317427
Company Name	US ENDODONTICS, LLC
Device Count	60
DM Exempt	true
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	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

Device Issuing Agency	Device ID
GS1	00818365020607 [Primary]
GS1	10818365020604 [Unit of Use]

EKM	GUTTA-PERCHA

Steralize Prior To Use	false
Device Is Sterile	false

10818365020642	MIS EdgeOne™ Paper Points Large
10818365020635	MIS EdgeOne™ Paper Points Medium
10818365020628	MIS EdgeOne™ Paper Points Primary
10818365020611	MIS EdgeOne™ Paper Points Small
10818365020604	MIS EdgeOne™ Gutta Percha Points Medium
10818365020598	MIS EdgeOne™ Gutta Percha Points Primary
10818365020581	MIS EdgeOne™ Gutta Percha Points Small
10818365020475	MIS EdgeOne™ Gutta Percha Points Large