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    FDA UDI In Commercial Distribution 🇺🇸 United States

    4.0 - ACUTRAK 3 STANDARD INSTRUMENT KIT (1027-004)

    DI: 00857676008973 · Model: 1027-004 · Eca Medical Instruments
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    4.0 - ACUTRAK 3 STANDARD INSTRUMENT KIT (1027-004)
    Primary DI
    00857676008973
    Version / Model
    1027-004
    Catalog Number
    1027-004
    Company Name
    Eca Medical Instruments
    Labeler DUNS
    084330422
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-11
    Public Version
    2
    Public Version Date
    2025-11-26
    Public Version Status
    Update
    Public Device Record Key
    41c3b80f-4e11-4dc0-b1b5-fb49fe48f3c8

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44052 Orthopaedic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00857676008973