BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Burn out core U Cylinder

    DI: 08800039324052 · Model: UMPSR55BT · InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Burn out core U Cylinder
    Primary DI
    08800039324052
    Version / Model
    UMPSR55BT
    Company Name
    InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
    Labeler DUNS
    631169224
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-28
    Public Version
    1
    Public Version Date
    2018-12-31
    Public Version Status
    New
    Public Device Record Key
    5aba65ef-0abf-4758-a2cb-0ecdea32d7a1

    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
    Yes
    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
    55847 Dental implant system

    Identifiers

    Type ID
    Primary 08800039324052

    Premarket Submissions

    Submission Number Supplement Number
    K173120 000