BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Guide ATOZ

    DI: 08800197900389 · Model: MK-G-08 · MK Meditech Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Guide ATOZ
    Primary DI
    08800197900389
    Version / Model
    MK-G-08
    Company Name
    MK Meditech Inc.
    Labeler DUNS
    695009476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-26
    Public Version
    1
    Public Version Date
    2025-01-03
    Public Version Status
    New
    Public Device Record Key
    fca5103d-889e-4c45-8802-9432a2d21a6c

    Device Description

    DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensure the correct orientation of the ATOZ Drill Bit or ATOZ screwdriver, facilitating the smooth placement of ATOZ Mini-Screws INDICATION FOR USE The Guide ATOZ is used to assist in the process of installing the ATOZ Expander. TRADE NAME Guide ATOZ MODEL NUMBER MK-G-08

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DYJ Retainer, Screw Expansion, Orthodontic

    GMDN Terms

    Code Name
    63675 Orthodontic retainer support kit

    Identifiers

    Type ID
    Primary 08800197900389