BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Styro-former, Basic SF319A

    DI: 00850077007170 · Model: SF319A · HUESTIS MACHINE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Styro-former, Basic SF319A
    Primary DI
    00850077007170
    Version / Model
    SF319A
    Company Name
    HUESTIS MACHINE CORPORATION
    Labeler DUNS
    001188390
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    18ac3cc0-a757-40d5-bdc6-aed9d2386b21

    Device Description

    Styro-former shielding block cutter cuts foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment,

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    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
    KPY Shield, Protective, Personnel

    GMDN Terms

    Code Name
    37079 Radiation therapy beam block production hot-wire

    Identifiers

    Type ID
    Primary 00850077007170