BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Unity Total Knee System

    DI: 05055343899274 · Model: 1231004 · CORIN LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Unity Total Knee System
    Primary DI
    05055343899274
    Version / Model
    1231004
    Catalog Number
    1231004
    Company Name
    CORIN LTD
    Labeler DUNS
    295437313
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-20
    Public Version
    3
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    de2eac32-02de-4e76-9854-6597555d257d

    Device Description

    Unity ASC Femoral Trial Main Body Size 4

    Device Characteristics

    Single Use
    No
    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
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    GMDN Terms

    Code Name
    58715 Knee femur prosthesis trial, reusable

    Identifiers

    Type ID
    Primary 05055343899274

    Premarket Submissions

    Submission Number Supplement Number
    K113060 000