BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-CEL X-RAY CORPORATION

    DI: B216HF718BD1 · Model: HF 718BD · ARQUILLA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-CEL X-RAY CORPORATION
    Primary DI
    B216HF718BD1
    Version / Model
    HF 718BD
    Company Name
    ARQUILLA, INC.
    Labeler DUNS
    062469945
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-27
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    677eb1ef-3ac5-4109-a972-2762031e75f5

    Device Description

    PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV

    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
    KPR System, X-Ray, Stationary

    GMDN Terms

    Code Name
    37644 Stationary basic diagnostic x-ray system, analogue

    Identifiers

    Type ID
    Primary B216HF718BD1

    Customer Contacts

    Phone
    8154552470
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K160857 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    50 – 90 Degrees Fahrenheit