BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-ray Beam Filter Kit

    DI: 40889978154117 · Model: X-ray Beam Filter Kit · CARESTREAM HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-ray Beam Filter Kit
    Primary DI
    40889978154117
    Version / Model
    X-ray Beam Filter Kit
    Catalog Number
    8154114
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    c20fd719-97e0-4391-8c66-78c3b33264b8

    Device Description

    4X4 X-ray Beam Filter Kit

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPW Device, beam limiting, x-ray, diagnostic

    GMDN Terms

    Code Name
    40918 X-ray/radiation therapy beam filter, sheet

    Identifiers

    Type ID
    Package 60889978154111
    Primary 40889978154117

    Premarket Submissions

    Submission Number Supplement Number
    K837334 000