EdgeOne Platinum Paper Points EOPLGPP

GUDID 10810047644252

Absorbent Paper Points

US ENDODONTICS, LLC

Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point
Primary Device ID10810047644252
NIH Device Record Keyaa10681e-a99f-4ae9-944b-90cd5304951f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeOne Platinum Paper Points
Version Model NumberEOPLGPP
Catalog NumberEOPLGPP
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
GS100810047644255 [Primary]
GS110810047644252 [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 Platinum Paper Points]

10810047644269Absorbent Paper Points
10810047644276Absorbent Paper Points
10810047644252Absorbent Paper Points
10810047644207Absorbent Paper Points

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