BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sonus Nose Cone

    DI: 00862872000348 · Model: 806-1105 · ENGLER ENGINEERING CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sonus Nose Cone
    Primary DI
    00862872000348
    Version / Model
    806-1105
    Catalog Number
    806-1105
    Company Name
    ENGLER ENGINEERING CORPORATION
    Labeler DUNS
    002965168
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-04
    Public Version
    1
    Public Version Date
    2021-05-12
    Public Version Status
    New
    Public Device Record Key
    0957d19a-6aee-41db-b147-ae613d1ee4b7

    Device Description

    White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device)

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    44908 Ultrasonic dental scaling/debridement system handpiece tip, periodontal

    Identifiers

    Type ID
    Primary 00862872000348

    Premarket Submissions

    Submission Number Supplement Number
    K811396 000