BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Foramatron®

    DI: 00810000520268 · Model: D619WAE · PARKELL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Foramatron®
    Primary DI
    00810000520268
    Version / Model
    D619WAE
    Catalog Number
    D619WAE
    Company Name
    PARKELL, INC.
    Labeler DUNS
    009900424
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-16
    Public Version
    2
    Public Version Date
    2020-11-24
    Public Version Status
    Update
    Public Device Record Key
    fd3a6cf2-369d-49d5-9875-c88595b09c52
    Distribution End Date
    2020-09-24

    Device Description

    Wire Assembly with 2-Ground Clips for Foramatron® IV D610E E

    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
    No
    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
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Primary 00810000520268

    Customer Contacts

    Phone
    6312491134
    Email
    [email protected]