BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    DX-54 Paper Pak

    DI: H665180351 · Model: 18035 · Flow X Ray Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    DX-54 Paper Pak
    Primary DI
    H665180351
    Version / Model
    18035
    Catalog Number
    18035
    Company Name
    Flow X Ray Corporation
    Labeler DUNS
    010016319
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2016-08-15
    Public Version
    5
    Public Version Date
    2023-06-28
    Public Version Status
    Update
    Public Device Record Key
    3e4230c9-7adc-4efd-aba5-24ae3d546d8e
    Distribution End Date
    2023-06-22

    Device Description

    D Speed Size 0 Child film in paper packets. 100 films per box

    Device Characteristics

    Single Use
    Yes
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IWZ Film, Radiographic

    GMDN Terms

    Code Name
    40978 Dental x-ray film, non-screen

    Identifiers

    Type ID
    Primary H665180351
    Unit of Use H665180350
    Secondary 00812045030030