BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultrasonic Tips

    DI: 00195062030697 · Model: 973-0037 · Kerr Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ultrasonic Tips
    Primary DI
    00195062030697
    Version / Model
    973-0037
    Company Name
    Kerr Corporation
    Labeler DUNS
    199354556
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-05
    Public Version
    1
    Public Version Date
    2021-03-15
    Public Version Status
    New
    Public Device Record Key
    65b7857b-1737-4626-a734-a8e1a47c74f4

    Device Description

    UT-3- S UPR LT /LWR RT UNIVERSAL TIP

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    46035 Ultrasonic dental scaling/debridement system handpiece tip, endodontic

    Identifiers

    Type ID
    Primary 00195062030697

    Customer Contacts

    Phone
    1-800-537-7123
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K934714 000