BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Root ZX mini

    DI: 04548213019434 · Model: RCM-7 · J.MORITA MFG.CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Root ZX mini
    Primary DI
    04548213019434
    Version / Model
    RCM-7
    Company Name
    J.MORITA MFG.CORP.
    Labeler DUNS
    693811465
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-12
    Public Version
    1
    Public Version Date
    2022-12-20
    Public Version Status
    New
    Public Device Record Key
    3fea59b3-054b-490a-8d80-cc4e9b371d8b

    Device Description

    Apex Locator

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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 04548213019434

    Premarket Submissions

    Submission Number Supplement Number
    K090925 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 85 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 45 Degrees Celsius