BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SNUCONE BONE LEVEL IMPLANT SYSTEM

    DI: 08800020854803 · Model: AF+B-5814S · SNUCONE Co.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SNUCONE BONE LEVEL IMPLANT SYSTEM
    Primary DI
    08800020854803
    Version / Model
    AF+B-5814S
    Company Name
    SNUCONE Co.,LTD.
    Labeler DUNS
    688806132
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-14
    Public Version
    1
    Public Version Date
    2023-02-22
    Public Version Status
    New
    Public Device Record Key
    34a89122-0465-4e45-81b3-b5df5d9d3a86

    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
    MR Conditional
    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 08800020854803

    Customer Contacts

    Phone
    9999999999
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K210354 000