BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Logical Dual Mobility CoCr Liner

    DI: 09348215112370 · Model: 01-042-01-0034 · SIGNATURE ORTHOPAEDICS PTY LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Logical Dual Mobility CoCr Liner
    Primary DI
    09348215112370
    Version / Model
    01-042-01-0034
    Company Name
    SIGNATURE ORTHOPAEDICS PTY LTD
    Labeler DUNS
    751993028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-13
    Public Version
    1
    Public Version Date
    2023-03-21
    Public Version Status
    New
    Public Device Record Key
    8032f721-f162-4d65-b843-22495e5a9051

    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
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    GMDN Terms

    Code Name
    48056 Metallic acetabular liner

    Identifiers

    Type ID
    Primary 09348215112370

    Premarket Submissions

    Submission Number Supplement Number
    K220495 000