BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premier

    DI: D6911006900 · Model: 1006900 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premier
    Primary DI
    D6911006900
    Version / Model
    1006900
    Company Name
    PREMIER DENTAL PRODUCTS COMPANY
    Labeler DUNS
    014789663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2019-11-18
    Public Version Status
    Update
    Public Device Record Key
    9a9acf09-5a7e-4ba0-8644-7978c825ccdc

    Device Description

    Resin handle Insert #10 Universal 30K

    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
    No
    PM Exempt
    No
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    36047 Ultrasonic dental scaling/debridement system

    Identifiers

    Type ID
    Primary D6911006900