BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Good Fit Instant Overdentures

    DI: 00817610024599 · Model: 817610024599 · GOOD FIT TECHNOLOGIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Good Fit Instant Overdentures
    Primary DI
    00817610024599
    Version / Model
    817610024599
    Company Name
    GOOD FIT TECHNOLOGIES, LLC
    Labeler DUNS
    080341158
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    a5ada11a-7279-4764-a0d0-e6acb19a345a

    Device Description

    Good Fit Instant Overdentures - Arch - DV - Lower - M2 - B1

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKO Denture Preformed (Partially Prefabricated Denture)

    GMDN Terms

    Code Name
    11172 Preformed complete denture

    Identifiers

    Type ID
    Primary 00817610024599