BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    i-ROOT 100

    DI: 08809455600658 · Model: iRB-009 · META SYSTEMS CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    i-ROOT 100
    Primary DI
    08809455600658
    Version / Model
    iRB-009
    Company Name
    META SYSTEMS CO., LTD.
    Labeler DUNS
    687503532
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-02
    Public Version
    2
    Public Version Date
    2021-06-16
    Public Version Status
    Update
    Public Device Record Key
    b5d66993-7a37-4f38-a1b7-989cc5ac5f7c
    Distribution End Date
    2021-06-15

    Device Description

    FILE HOLDER B FOR IROOT 100

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Primary 08809455600658

    Premarket Submissions

    Submission Number Supplement Number
    K112508 000