BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    The Orthodontic Store

    DI: 00840326409251 · Model: 620-006 · Young Innovations, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    The Orthodontic Store
    Primary DI
    00840326409251
    Version / Model
    620-006
    Catalog Number
    620-006
    Company Name
    Young Innovations, Inc.
    Labeler DUNS
    004193103
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-02
    Public Version
    1
    Public Version Date
    2022-11-10
    Public Version Status
    New
    Public Device Record Key
    ae55ec75-7bdf-471a-8547-36c921f11f6e

    Device Description

    LEONE 620 RPE SCREW, 9MM

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DYJ RETAINER, SCREW EXPANSION, ORTHODONTIC

    GMDN Terms

    Code Name
    65677 Orthodontic palate expander screw, bonded

    Identifiers

    Type ID
    Package 10840326409258
    Primary 00840326409251

    Customer Contacts

    Phone
    +1 (800) 558-6684
    Email
    [email protected]