BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WE-57 XT Alegra Contra-Angle 1:1 FG

    DI: J021304780001 · Model: 30478000 · W & H Dentalwerk Bürmoos GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WE-57 XT Alegra Contra-Angle 1:1 FG
    Primary DI
    J021304780001
    Version / Model
    30478000
    Company Name
    W & H Dentalwerk Bürmoos GmbH
    Labeler DUNS
    300238441
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-11
    Public Version
    1
    Public Version Date
    2023-07-19
    Public Version Status
    New
    Public Device Record Key
    3213f7ef-edef-4db5-96a3-fc357d60ee5a

    Device Description

    Alegra Contra-Angle Handpiece

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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

    GMDN Terms

    Code Name
    66245 Dental surgical power tool motorized handpiece/set, electric

    Identifiers

    Type ID
    Direct Marking J021304780000
    Primary J021304780001