BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EXULT Knee Replacement System

    DI: 08800017297217 · Model: KC.COT.E001 · Corentec Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EXULT Knee Replacement System
    Primary DI
    08800017297217
    Version / Model
    KC.COT.E001
    Company Name
    Corentec Co., Ltd
    Labeler DUNS
    688739895
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-09
    Public Version
    2
    Public Version Date
    2021-07-16
    Public Version Status
    Update
    Public Device Record Key
    9eee3fb2-c7e1-4417-adc2-c7d096b26a04

    Device Description

    Primary Stem Extension

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    61560 Sleeve femoral/tibial extension, uncoated

    Identifiers

    Type ID
    Primary 08800017297217

    Customer Contacts

    Phone
    +82414107176
    Email
    [email protected]