BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NORDENT MANUFACTURING INC.

    DI: 00840018658530 · Model: REND11T · NORDENT MANUFACTURING INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NORDENT MANUFACTURING INC.
    Primary DI
    00840018658530
    Version / Model
    REND11T
    Company Name
    NORDENT MANUFACTURING INC
    Labeler DUNS
    053187985
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-20
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    15a8f9fa-65e6-4f57-a04f-dd7acd883252

    Device Description

    Root Canal Spreader, SE, Nickle Titanium, #D11T (Thin)

    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 00840018658530