BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    RQ-03 Roto Quick

    DI: J021104003001 · Model: 10400300 · W & H Dentalwerk Bürmoos GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RQ-03 Roto Quick
    Primary DI
    J021104003001
    Version / Model
    10400300
    Company Name
    W & H Dentalwerk Bürmoos GmbH
    Labeler DUNS
    300238441
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-30
    Public Version
    2
    Public Version Date
    2023-07-04
    Public Version Status
    Update
    Public Device Record Key
    5ee07604-0573-49b8-9969-c93651580248
    Distribution End Date
    2023-07-03

    Device Description

    Coupling

    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
    EFB Handpiece, Air-Powered, Dental

    GMDN Terms

    Code Name
    45121 Pneumatic dental handpiece coupler

    Identifiers

    Type ID
    Direct Marking J021104003000
    Primary J021104003001