BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BURKHART DENTAL

    DI: 00840018604209 · Model: RCS11T/BH · 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
    00840018604209
    Version / Model
    RCS11T/BH
    Company Name
    NORDENT MANUFACTURING INC
    Labeler DUNS
    053187985
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-21
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    75a5f6e3-e746-488f-b637-9887f7f84f3a

    Device Description

    BDS RT CANL SPRD SE #D11T-NITI STD HN

    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
    EKK Spreader, Pulp Canal Filling Material, Endodontic

    GMDN Terms

    Code Name
    37678 Manual endodontic filling material spreader

    Identifiers

    Type ID
    Primary 00840018604209