BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OdneClean

    DI: 07649988156632 · Model: E-0003 · Odne AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OdneClean
    Primary DI
    07649988156632
    Version / Model
    E-0003
    Catalog Number
    E-0003
    Company Name
    Odne AG
    Labeler DUNS
    480237899
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-28
    Public Version
    1
    Public Version Date
    2024-12-06
    Public Version Status
    New
    Public Device Record Key
    6d8eb41f-70f5-4b5a-bdce-fb660bab2dea

    Device Description

    1 OdneClean Device containing hose, metal rod holder, handpiece, multiple connection hoses, hose for disinfection, plug and cable, 500 sleeves, IFU / manual

    Device Characteristics

    Single Use
    No
    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
    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
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    60930 Dental delivery system instrument unit, electric

    Identifiers

    Type ID
    Primary 07649988156632