BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-Wire

    DI: 00810111222181 · Model: 01-1000-007 · Treace Medical Concepts, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-Wire
    Primary DI
    00810111222181
    Version / Model
    01-1000-007
    Company Name
    Treace Medical Concepts, Inc.
    Labeler DUNS
    054808082
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-10
    Public Version
    1
    Public Version Date
    2023-11-20
    Public Version Status
    New
    Public Device Record Key
    35b612e5-48ee-40da-9861-d738ef8fb31c

    Device Description

    K-Wire

    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
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

    GMDN Terms

    Code Name
    66935 Orthopaedic intraoperative positioning pin, single-use

    Identifiers

    Type ID
    Primary 00810111222181