BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dynarex ActiSplint

    DI: 00616784352817 · Model: 3528 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dynarex ActiSplint
    Primary DI
    00616784352817
    Version / Model
    3528
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-01
    Public Version
    1
    Public Version Date
    2021-09-09
    Public Version Status
    New
    Public Device Record Key
    b138bca4-1b6b-491f-9450-8fa1cfb70567

    Device Description

    Dynarex ActiSplint Rolled, 36in. Rolled Splint, Breathable, Red/Charcoal Gray

    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
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile

    GMDN Terms

    Code Name
    63273 First aid limb splint, mouldable, reusable

    Identifiers

    Type ID
    Package 00616784352831
    Primary 00616784352817