BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rx Knee Tibial Cone Augment Size Stackable

    DI: 09348215147563 · Model: 121-25-0406 · SIGNATURE ORTHOPAEDICS PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rx Knee Tibial Cone Augment Size Stackable
    Primary DI
    09348215147563
    Version / Model
    121-25-0406
    Company Name
    SIGNATURE ORTHOPAEDICS PTY LTD
    Labeler DUNS
    751993028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-26
    Public Version
    1
    Public Version Date
    2025-09-03
    Public Version Status
    New
    Public Device Record Key
    b7eb3be3-a920-4706-bc4c-aa0cce0ec4aa

    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    GMDN Terms

    Code Name
    67099 Temporary knee prosthesis, non-customized

    Identifiers

    Type ID
    Primary 09348215147563