BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PB Uni tibial trial insert

    DI: 04048844031022 · Model: 40120309 · implantcast GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PB Uni tibial trial insert
    Primary DI
    04048844031022
    Version / Model
    40120309
    Company Name
    implantcast GmbH
    Labeler DUNS
    324369826
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-15
    Public Version
    3
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    34725a12-5134-4fa2-a0e4-0af32e8b60d8

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

    GMDN Terms

    Code Name
    58716 Knee tibia prosthesis trial, reusable

    Identifiers

    Type ID
    Primary 04048844031022

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 3 9mm