EQ-PEX

GUDID 08809455601167

META SYSTEMS CO., LTD.

Endodontic apex locator
Primary Device ID08809455601167
NIH Device Record Key5c92628f-bd49-4722-96a9-bda6542ff426
Commercial Distribution StatusIn Commercial Distribution
Brand NameEQ-PEX
Version Model NumberP2901
Company DUNS687503532
Company NameMETA SYSTEMS CO., LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809455601167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


[08809455601167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-18
Device Publish Date2022-01-10

Devices Manufactured by META SYSTEMS CO., LTD.

08809455600917 - EQ-M2023-07-18 Cordless Endodontic Motor Kit - US
08809455601402 - Elements Connect2022-11-25 Elements Connect Cordless Motor Kit - EU
08809455601921 - Elements Connect2022-11-25 Elements Connect Cordless Motor Kit - US
08809455601938 - Elements Connect2022-11-25 Elements Connect Motor Handpiece
08809455601945 - Elements Connect2022-11-25 Elements Connect Contra Angle
08809455601952 - Elements Connect2022-11-25 Elements Connect Charging Base
08809455601419 - Apex Connect2022-11-24 Apex Connect Kit - EU
08809455601969 - Apex Connect2022-11-24 Apex Connect Kit - US

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