BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monarch

    DI: 05056079036216 · Model: Anterior L1 Lower C2 · WRIGHT HEALTH GROUP LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Monarch
    Primary DI
    05056079036216
    Version / Model
    Anterior L1 Lower C2
    Catalog Number
    MONL1LC2
    Company Name
    WRIGHT HEALTH GROUP LIMITED
    Labeler DUNS
    214045304
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-01
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b0d64f1e-c9bf-435d-92d9-be97b15e9119

    Device Description

    Polymer Teeth - Set

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELM Denture, Plastic, Teeth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary 05056079036216

    Customer Contacts

    Phone
    +1(800)847-4209
    Email
    [email protected]