BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EdgeTip™ #3

    DI: 00818365020164 · Model: ET20D · EDGE ENDO LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EdgeTip™ #3
    Primary DI
    00818365020164
    Version / Model
    ET20D
    Company Name
    EDGE ENDO LLC
    Labeler DUNS
    078474365
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-10
    Public Version
    2
    Public Version Date
    2019-02-21
    Public Version Status
    Update
    Public Device Record Key
    847149fd-c965-4c8c-9244-557c0f5855b7

    Device Description

    Diamond-coated retreatment tip for the removal of very hard materials in the first crown

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELC Scaler, Ultrasonic

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00818365020164