BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DARCO® WCS™ / WCS™ Light Insoles

    DI: 00609271279643 · Model: WCI2/R · Darco (Europe) GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    DARCO® WCS™ / WCS™ Light Insoles
    Primary DI
    00609271279643
    Version / Model
    WCI2/R
    Catalog Number
    WCI2/R
    Company Name
    Darco (Europe) GmbH
    Labeler DUNS
    343551081
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-08
    Public Version
    3
    Public Version Date
    2025-06-27
    Public Version Status
    Update
    Public Device Record Key
    ded8be12-0027-4147-be35-a40bffe72c22

    Device Description

    M Orange/White/Blue Right

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNP ORTHOSIS, CORRECTIVE SHOE

    GMDN Terms

    Code Name
    41575 Orthotic insole, prefabricated, non-antimicrobial

    Identifiers

    Type ID
    Package 20609271279647
    Primary 00609271279643