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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Duracon

    DI: 07613327050264 · Model: 6478-6-495 · Howmedica Osteonics Corp.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Duracon
    Primary DI
    07613327050264
    Version / Model
    6478-6-495
    Catalog Number
    6478-6-495
    Company Name
    Howmedica Osteonics Corp.
    Labeler DUNS
    058311945
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    4
    Public Version Date
    2020-04-20
    Public Version Status
    Update
    Public Device Record Key
    c6bceacf-c2d4-4d2e-8270-d88b08d913be

    Device Description

    Total Stabilizer Offset Adapter

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    48066 Knee femur stem prosthesis

    Identifiers

    Type ID
    Primary 07613327050264

    Premarket Submissions

    Submission Number Supplement Number
    K060360 000
    K973164 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Offset: 6.0 Millimeter