BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BURKHART DENTAL

    DI: 00840018603790 · Model: IS204S/6BH · NORDENT MANUFACTURING INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BURKHART DENTAL
    Primary DI
    00840018603790
    Version / Model
    IS204S/6BH
    Company Name
    NORDENT MANUFACTURING INC
    Labeler DUNS
    053187985
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-21
    Public Version
    1
    Public Version Date
    2020-05-29
    Public Version Status
    New
    Public Device Record Key
    c4a584bb-32de-4311-9784-4fe388d1af2e
    Distribution End Date
    2020-05-21

    Device Description

    BURKHART IMPLANT SCALER DE 204S 10MM HDL

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    ELA Instrument, Hand, Calculus Removal

    GMDN Terms

    Code Name
    35320 Manual dental scaler, reusable

    Identifiers

    Type ID
    Primary 00840018603790