BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DARCO® OrthoWedge™ healing shoe

    DI: 00609271819450 · Model: OQ4B · DARCO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DARCO® OrthoWedge™ healing shoe
    Primary DI
    00609271819450
    Version / Model
    OQ4B
    Catalog Number
    OQ4B; OW4B-ST
    Company Name
    DARCO INTERNATIONAL, INC.
    Labeler DUNS
    184231298
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-08
    Public Version
    1
    Public Version Date
    2023-02-16
    Public Version Status
    New
    Public Device Record Key
    fabc2f6b-90da-4b86-adc4-2a580938705e

    Device Description

    Extra-large Black Square-toe

    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
    31041 Orthotic shoe, non-customized

    Identifiers

    Type ID
    Package 10609271819457
    Primary 00609271819450
    Package 20609271819454