BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sonoma Orthopedic Products, Inc

    DI: 00816988011835 · Model: Compression Driver · ARTHREX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sonoma Orthopedic Products, Inc
    Primary DI
    00816988011835
    Version / Model
    Compression Driver
    Catalog Number
    IN6040
    Company Name
    ARTHREX, INC.
    Labeler DUNS
    131747628
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-19
    Public Version
    3
    Public Version Date
    2020-07-08
    Public Version Status
    Update
    Public Device Record Key
    9aed9b39-7749-4c27-b40d-e114233606c1
    Distribution End Date
    2020-07-07

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    48025 Orthopaedic bone-fragment manipulator, reusable

    Identifiers

    Type ID
    Primary 00816988011835