EdgeOne Fire™ MEOFMEDPP

GUDID 10818365020635

MIS EdgeOne™ Paper Points Medium

US ENDODONTICS, LLC

Endodontic paper point
Primary Device ID10818365020635
NIH Device Record Key5b82dd93-e883-42d2-84cb-7e918287b55f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeOne Fire™
Version Model NumberMEOFMEDPP
Catalog NumberMEOFMEDPP
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 Datetrue
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
GS100818365020638 [Primary]
GS110818365020635 [Unit of Use]

FDA Product Code

EKNPOINT, PAPER, ENDODONTIC

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 [EdgeOne Fire™]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.