EdgeSequel Utopia ES250625SE

GUDID 10810047645518

Sterile Endodontic Rotary File

US ENDODONTICS, LLC

Rotary/reciprocating endodontic file/rasp, reusable
Primary Device ID10810047645518
NIH Device Record Key9d7c3756-28c2-40fb-a196-8a66b6016bd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeSequel Utopia
Version Model NumberES250625SE
Catalog NumberES250625SE
Company DUNS061317427
Company NameUS ENDODONTICS, LLC
Device Count6
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810047645511 [Primary]
GS110810047645518 [Unit of Use]

FDA Product Code

EKSFILE, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-28

On-Brand Devices [EdgeSequel Utopia]

10810047645648Sterile Endodontic Rotary File
10810047645631Sterile Endodontic Rotary File
10810047645624Sterile Endodontic Rotary File
10810047645617Sterile Endodontic Rotary File
10810047645600Sterile Endodontic Rotary File
10810047645594Sterile Endodontic Rotary File
10810047645587Sterile Endodontic Rotary File
10810047645570Sterile Endodontic Rotary File
10810047645563Sterile Endodontic Rotary File
10810047645556Sterile Endodontic Rotary File
10810047645549Sterile Endodontic Rotary File
10810047645532Sterile Endodontic Rotary File
10810047645525Sterile Endodontic Rotary File
10810047645518Sterile Endodontic Rotary File
10810047645501Sterile Endodontic Rotary File
10810047645495Sterile Endodontic Rotary File
10810047645488Sterile Endodontic Rotary File
10810047645471Sterile Endodontic Rotary File
10810047645464Sterile Endodontic Rotary File
10810047645457Sterile Endodontic Rotary File
10810047645440Sterile Endodontic Rotary File
10810047645433Sterile Endodontic Rotary File
10810047645426Sterile Endodontic Rotary File
10810047645419Sterile Endodontic Rotary File
10810047645402Sterile Endodontic Rotary File
10810047645396Sterile Endodontic Rotary File
10810047645389Sterile Endodontic Rotary File
10810047645372Sterile Endodontic Rotary File
10810047645365Sterile Endodontic Rotary File
10810047645358Sterile Endodontic Rotary File

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