BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DX-D 300

    DI: 05414904079607 · Model: 8207/050 · AGFA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DX-D 300
    Primary DI
    05414904079607
    Version / Model
    8207/050
    Catalog Number
    5NBXP
    Company Name
    AGFA
    Labeler DUNS
    374444883
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    4
    Public Version Date
    2019-06-14
    Public Version Status
    Update
    Public Device Record Key
    91c0e43c-db82-4163-ba54-08e2b3fa766e

    Device Description

    DX-D 300 MASTER CODE

    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
    37645 Stationary basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 05414904079607

    Customer Contacts

    Phone
    +1(877)777-2432
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103050 000