BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MiniX-S

    DI: 08800021800021 · Model: 1 · DigiMed Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    9
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MiniX-S
    Primary DI
    08800021800021
    Version / Model
    1
    Catalog Number
    1
    Company Name
    DigiMed Co., Ltd.
    Labeler DUNS
    688265810
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-19
    Public Version
    4
    Public Version Date
    2019-04-01
    Public Version Status
    Update
    Public Device Record Key
    dba0ff16-f300-4520-a67a-ff2e050b8e0b

    Device Description

    The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The device is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both.

    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
    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
    No

    Product Codes

    Code Name
    EHD Unit, X-Ray, Extraoral With Timer

    GMDN Terms

    Code Name
    44606 Hand-held intraoral dental x-ray system, digital

    Identifiers

    Type ID
    Package 88800021800027
    Primary 08800021800021
    Package 78800021800020
    Package 68800021800023
    Package 58800021800026
    Package 48800021800029
    Package 38800021800022
    Package 28800021800025
    Package 18800021800028

    Customer Contacts

    Phone
    +82226241552
    Email
    [email protected]
    Phone
    +82226241551
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    5 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 35 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 85 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal