BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    U2 Total Knee System

    DI: 04719872178156 · Model: 9304-8120 · UNITED ORTHOPEDIC CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    U2 Total Knee System
    Primary DI
    04719872178156
    Version / Model
    9304-8120
    Catalog Number
    9304-8120
    Company Name
    UNITED ORTHOPEDIC CORP.
    Labeler DUNS
    656700556
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-25
    Public Version
    6
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    08e6ac7a-fc9b-48ad-a028-6113accde91b

    Device Description

    U2 Knee AiO tibia and onset patella case

    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
    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
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 04719872178156

    Customer Contacts

    Phone
    +886229294567
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K082424 000