BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pomee

    DI: G1577047700 · Model: 704-770 · POMEE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pomee
    Primary DI
    G1577047700
    Version / Model
    704-770
    Catalog Number
    704-770
    Company Name
    POMEE CORPORATION
    Labeler DUNS
    645717646
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-29
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    f303dbf9-b314-45b9-8679-adc36176236b

    Device Description

    Root Canal Spreader # D II

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    EIX Probe, Periodontic

    GMDN Terms

    Code Name
    37678 Manual endodontic filling material spreader

    Identifiers

    Type ID
    Primary G1577047700