BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INSERT CC 26 X 60

    DI: M209118010 · Model: 11801 · BIOPRO, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    INSERT CC 26 X 60
    Primary DI
    M209118010
    Version / Model
    11801
    Company Name
    BIOPRO, INC.
    Labeler DUNS
    618749857
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-16
    Public Version
    4
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    53e6bdb7-4973-412f-ae90-a6547b227df4

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    GMDN Terms

    Code Name
    34199 Polyethylene patella prosthesis

    Identifiers

    Type ID
    Primary M209118010

    Premarket Submissions

    Submission Number Supplement Number
    K904448 000