BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    One Stage TL SP

    DI: 00850008541018 · Model: i311020 · I3 IMPLANT LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    One Stage TL SP
    Primary DI
    00850008541018
    Version / Model
    i311020
    Company Name
    I3 IMPLANT LLC
    Labeler DUNS
    026108395
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-27
    Public Version
    2
    Public Version Date
    2019-07-01
    Public Version Status
    Update
    Public Device Record Key
    b0637e8c-9f7b-480f-86c2-66d6ac98c492

    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
    No
    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
    61642 Dental implant analog

    Identifiers

    Type ID
    Primary 00850008541018