BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SMART SEAL LINER

    DI: 00713980010449 · Model: SADT38-6 · Alps South, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SMART SEAL LINER
    Primary DI
    00713980010449
    Version / Model
    SADT38-6
    Company Name
    Alps South, LLC
    Labeler DUNS
    824697569
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-30
    Public Version
    1
    Public Version Date
    2025-01-07
    Public Version Status
    New
    Public Device Record Key
    f6b2f048-66a2-4548-a3ab-b3f8017cdee9

    Device Description

    Smart Seal AK 38-6 Locking Liner

    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
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISS Prosthesis, Thigh Socket, External Component

    GMDN Terms

    Code Name
    41536 External limb prosthesis socket liner

    Identifiers

    Type ID
    Primary 00713980010449