BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Comprehensive Modular Hybrid Glenoid

    DI: 00880304848337 · Model: SSI003626 · Biomet Orthopedics, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Comprehensive Modular Hybrid Glenoid
    Primary DI
    00880304848337
    Version / Model
    SSI003626
    Catalog Number
    SSI003626
    Company Name
    Biomet Orthopedics, LLC
    Labeler DUNS
    129278169
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-03
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d63a8d31-4ef9-4175-b362-815788774284

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    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
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

    GMDN Terms

    Code Name
    60927 Glenoid orthopaedic reamer

    Identifiers

    Type ID
    Primary 00880304848337

    Customer Contacts

    Phone
    1(800)348-9500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K060694 000