BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BenTips Stubby Tri A3

    DI: D966T15V331 · Model: T15v3.3 · BENNETT JACOBY, DDS, MS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    BenTips Stubby Tri A3
    Primary DI
    D966T15V331
    Version / Model
    T15v3.3
    Company Name
    BENNETT JACOBY, DDS, MS, INC.
    Labeler DUNS
    031283428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2022-02-17
    Public Version
    1
    Public Version Date
    2022-02-25
    Public Version Status
    New
    Public Device Record Key
    ab7db962-5a0b-4e7f-9343-b4404519ca8f

    Device Characteristics

    Single Use
    Yes
    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
    DZI Drill, Bone, Powered

    GMDN Terms

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

    Identifiers

    Type ID
    Unit of Use D966T15V330
    Primary D966T15V331

    Premarket Submissions

    Submission Number Supplement Number
    K192033 000