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    FDA UDI In Commercial Distribution 🇺🇸 United States

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    DI: 04262429650150 · Model: 0108(1/2)xxx · macu4 GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Explorer Pinch Module spacer
    Primary DI
    04262429650150
    Version / Model
    0108(1/2)xxx
    Company Name
    macu4 GmbH
    Labeler DUNS
    344157954
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-23
    Public Version
    1
    Public Version Date
    2025-12-01
    Public Version Status
    New
    Public Device Record Key
    8ecad5bf-8f13-4b93-a1df-b74490b6a5c4

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISZ Unit, Wrist, External Limb Component, Mechanical

    GMDN Terms

    Code Name
    41078 Passive hand prosthesis

    Identifiers

    Type ID
    Primary 04262429650150