i-ROOT 100

GUDID 08809455600634

i-ROOT 100

META SYSTEMS CO., LTD.

Endodontic apex locator
Primary Device ID08809455600634
NIH Device Record Keydfe15289-ae85-41f2-998e-9d6866b45a11
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-ROOT 100
Version Model NumberiRB-003
Company DUNS687503532
Company NameMETA SYSTEMS CO., LTD.
Device Count1
DM Exemptfalse
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
GS108809455600634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

On-Brand Devices [i-ROOT 100]

08809455600672PROBE CORD FOR IROOT 100
08809455600665LIP HOLDER FOR IROOT 100
08809455600658FILE HOLDER B FOR IROOT 100
08809455600641FILE HOLDER A FOR IROOT 100
08809455600634i-ROOT 100

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