BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Unity Total Knee System

    DI: 05055343881583 · Model: 112.004.96 · 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
    05055343881583
    Version / Model
    112.004.96
    Catalog Number
    112.004.96
    Company Name
    CORIN LTD
    Labeler DUNS
    295437313
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-17
    Public Version
    4
    Public Version Date
    2020-04-20
    Public Version Status
    Update
    Public Device Record Key
    33e27d13-a0b2-4be8-9441-22d1e83929c7

    Device Description

    Unity Offset stem extention. 6mm

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    GMDN Terms

    Code Name
    48066 Knee femur stem prosthesis

    Identifiers

    Type ID
    Primary 05055343881583

    Customer Contacts

    Phone
    +441285659866 ext. 2118
    Email
    [email protected]
    Phone
    +441285659866 ext. 2203
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K113060 000