BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMERICAN ORTHODONTICS

    DI: 00840018600126 · Model: 010-009 · NORDENT MANUFACTURING INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMERICAN ORTHODONTICS
    Primary DI
    00840018600126
    Version / Model
    010-009
    Company Name
    NORDENT MANUFACTURING INC
    Labeler DUNS
    053187985
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-28
    Public Version
    2
    Public Version Date
    2023-01-20
    Public Version Status
    Update
    Public Device Record Key
    6c08d812-3751-4a9d-86eb-15fe918e8ad1

    Device Description

    AO SE EXPLORER 23

    Device Characteristics

    Single Use
    Yes
    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
    EKB Explorer, Operative

    GMDN Terms

    Code Name
    35812 Dental surgical probe, reusable

    Identifiers

    Type ID
    Primary 00840018600126