BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WK-900 LT, Synea Vision

    DI: J021304180001 · Model: 30418000 · W & H Dentalwerk Bürmoos GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WK-900 LT, Synea Vision
    Primary DI
    J021304180001
    Version / Model
    30418000
    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
    2023-11-15
    Public Version
    1
    Public Version Date
    2023-11-23
    Public Version Status
    New
    Public Device Record Key
    09d284ec-4698-4f18-94c5-d218b5f1d5a1

    Device Description

    WK-900 LT, Synea Vision, Contra-Angle Handpiece 1:4

    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 J021304180000
    Primary J021304180001