BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PS CONSTRAINED INSERT XLG

    DI: 08428898186231 · Model: 178912 · BIOMET SPAIN ORTHOPAEDICS SL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PS CONSTRAINED INSERT XLG
    Primary DI
    08428898186231
    Version / Model
    178912
    Catalog Number
    178912
    Company Name
    BIOMET SPAIN ORTHOPAEDICS SL
    Labeler DUNS
    460900553
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-11
    Public Version
    3
    Public Version Date
    2022-03-10
    Public Version Status
    Update
    Public Device Record Key
    36ee4dc4-1353-4c3e-8453-ec92aa5cb1bb

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    46585 Tibial insert

    Identifiers

    Type ID
    Primary 08428898186231

    Customer Contacts

    Phone
    +1(800)342-5454
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 22MM