BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COXO

    DI: 06974267891272 · Model: CX207-B · Foshan COXO Medical Instrument Co.,Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COXO
    Primary DI
    06974267891272
    Version / Model
    CX207-B
    Company Name
    Foshan COXO Medical Instrument Co.,Ltd.
    Labeler DUNS
    529860171
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-27
    Public Version
    1
    Public Version Date
    2024-04-04
    Public Version Status
    New
    Public Device Record Key
    ba0aea8f-e1c1-4b6b-9bc5-0f6b4c1072d6

    Device Description

    High-Speed Air Turbine Handpieces

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    EFB Handpiece, Air-Powered, Dental
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

    GMDN Terms

    Code Name
    66228 Dental surgical power tool motor, pneumatic

    Identifiers

    Type ID
    Primary 06974267891272

    Premarket Submissions

    Submission Number Supplement Number
    K220179 000