BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sonoma Orthopedic Products, Inc.

    DI: 00816988013013 · Model: 4.0mm Distal Reamer Jones Bolt, Non-Sterile · 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
    00816988013013
    Version / Model
    4.0mm Distal Reamer Jones Bolt, Non-Sterile
    Catalog Number
    CS7140-C
    Company Name
    ARTHREX, INC.
    Labeler DUNS
    131747628
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-04
    Public Version
    7
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    adb785f6-ddf4-439b-b7d4-05fbca7041b6
    Distribution End Date
    2020-07-08

    Device Characteristics

    Single Use
    Yes
    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
    HTO Reamer

    GMDN Terms

    Code Name
    61235 Cannulated surgical drill bit, single-use

    Identifiers

    Type ID
    Primary 00816988013013