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    FDA UDI In Commercial Distribution 🇺🇸 United States

    index Asurity

    DI: 16945630137584 · Model: Index Asurity 3# SS 11# · Sterilance Medical (Suzhou) Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    index Asurity
    Primary DI
    16945630137584
    Version / Model
    Index Asurity 3# SS 11#
    Company Name
    Sterilance Medical (Suzhou) Inc.
    Labeler DUNS
    554434897
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2025-08-26
    Public Version
    1
    Public Version Date
    2025-09-03
    Public Version Status
    New
    Public Device Record Key
    178085bb-3a76-49ab-8eb4-3a9142e82afe

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    GDX Scalpel, One-Piece

    GMDN Terms

    Code Name
    37445 Manual scalpel blade, single-use

    Identifiers

    Type ID
    Package 36945630137588
    Primary 16945630137584
    Unit of Use 06945630137587