BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EM-E8 LED

    DI: J021105308001 · Model: 10530800 · W & H Dentalwerk Bürmoos GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EM-E8 LED
    Primary DI
    J021105308001
    Version / Model
    10530800
    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
    2019-09-10
    Public Version
    2
    Public Version Date
    2023-06-27
    Public Version Status
    Update
    Public Device Record Key
    08c2a78f-6b87-46c5-a4fb-ceb8aa77cb6f

    Device Description

    Built-in Motor

    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
    No

    Product Codes

    Code Name
    EBW Controller, Foot, Handpiece And Cord

    GMDN Terms

    Code Name
    66227 Dental surgical power tool motor, electric

    Identifiers

    Type ID
    Direct Marking J021105308000
    Primary J021105308001