BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BI-MENTUM PE Liner

    DI: 03662200015511 · Model: BI-MENTUM PE Liner 22,2 / 45 · SOC ETUDES RECHERCHES FABRICATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BI-MENTUM PE Liner
    Primary DI
    03662200015511
    Version / Model
    BI-MENTUM PE Liner 22,2 / 45
    Company Name
    SOC ETUDES RECHERCHES FABRICATION
    Labeler DUNS
    282651413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-15
    Public Version
    1
    Public Version Date
    2019-02-15
    Public Version Status
    New
    Public Device Record Key
    10736d62-ab5b-40c4-b2d6-356cb7adfe97

    Device Description

    BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner

    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    GMDN Terms

    Code Name
    43168 Non-constrained polyethylene acetabular liner

    Identifiers

    Type ID
    Primary 03662200015511