BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 06009544042754 · Model: TS-SP-MC · SOUTHERN IMPLANTS (PTY) LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    N/A
    Primary DI
    06009544042754
    Version / Model
    TS-SP-MC
    Company Name
    SOUTHERN IMPLANTS (PTY) LTD
    Labeler DUNS
    636239584
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-26
    Public Version
    1
    Public Version Date
    2024-03-05
    Public Version Status
    New
    Public Device Record Key
    f9b87bbe-3730-45e4-9c44-9ddca18b1043

    Device Description

    Screw Angled CC SP1 Hexed Titanium Screw for SP1 Angled Compact Conica

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    61647 Dental prosthesis/implant abutment screw

    Identifiers

    Type ID
    Primary 06009544042754

    Premarket Submissions

    Submission Number Supplement Number
    K232418 000