BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ICON

    DI: 00810152070918 · Model: ICONTOOL · Orthoshop, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ICON
    Primary DI
    00810152070918
    Version / Model
    ICONTOOL
    Catalog Number
    ICONTOOL
    Company Name
    Orthoshop, LLC
    Labeler DUNS
    129808388
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-24
    Public Version
    1
    Public Version Date
    2023-12-04
    Public Version Status
    New
    Public Device Record Key
    10c7bc14-6479-44e7-a94e-c2dde0b3c431

    Device Description

    ICON Self-Ligating Opening Instrument

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ECP Instrument, Ligature Tucking, Orthodontic

    GMDN Terms

    Code Name
    62086 Self-ligating orthodontic bracket open/close tool

    Identifiers

    Type ID
    Primary 00810152070918