BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UV Active Implant System

    DI: 08800049232200 · Model: UF(II) 6013UV3 · DIO Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UV Active Implant System
    Primary DI
    08800049232200
    Version / Model
    UF(II) 6013UV3
    Catalog Number
    UF(II) 6013UV3
    Company Name
    DIO Corporation
    Labeler DUNS
    631085206
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-10
    Public Version
    2
    Public Version Date
    2024-01-12
    Public Version Status
    Update
    Public Device Record Key
    177a1796-c957-442f-89fb-c7172aca9fea

    Device Description

    Ø5.9X13mm

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55849 Screw endosteal dental implant, two-piece

    Identifiers

    Type ID
    Primary 08800049232200

    Premarket Submissions

    Submission Number Supplement Number
    K182194 000