EdgeTaper Platinum™ METF1GP

GUDID 10818365020482

MIS EdgeTaper Gutta Percha Points F1

US ENDODONTICS, LLC

Synthetic gutta-percha
Primary Device ID10818365020482
NIH Device Record Keydd2f5362-f74a-4e5a-adbf-86c6598e409f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeTaper Platinum™
Version Model NumberMETF1GP
Catalog NumberMETF1GP
Company DUNS061317427
Company NameUS ENDODONTICS, LLC
Device Count60
DM Exempttrue
Pre-market Exempttrue
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

Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com
Phone+1(423)283-0047
EmailBobby.bennett@us-endo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100818365020485 [Primary]
GS110818365020482 [Unit of Use]

FDA Product Code

EKMGUTTA-PERCHA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-25

On-Brand Devices [EdgeTaper Platinum™]

10818365020758EdgeTaper Platinum™ Bioceramic Gutta Percha Points F5
10818365020741EdgeTaper Platinum™ Bioceramic Gutta Percha Points F4
10818365020734EdgeTaper Platinum™ Bioceramic Gutta Percha Points F3
10818365020727EdgeTaper Platinum™ Bioceramic Gutta Percha Points F2
10818365020710EdgeTaper Platinum™ Bioceramic Gutta Percha Points F1
10818365020574MIS EdgeTaper Paper Points F5
10818365020567MIS EdgeTaper Paper Points F4
10818365020550MIS EdgeTaper Paper Points F3
10818365020543MIS EdgeTaper Paper Points F2
10818365020536MIS EdgeTaper Paper Points F1
10818365020529MIS EdgeTaper Gutta Percha Points F5
10818365020512MIS EdgeTaper Gutta Percha Points F4
10818365020505MIS EdgeTaper Gutta Percha Points F3
10818365020499MIS EdgeTaper Gutta Percha Points F2
10818365020482MIS EdgeTaper Gutta Percha Points F1

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