BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CI E

    DI: 03662200005925 · Model: CI 67/22,2 E · SOC ETUDES RECHERCHES FABRICATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CI E
    Primary DI
    03662200005925
    Version / Model
    CI 67/22,2 E
    Company Name
    SOC ETUDES RECHERCHES FABRICATION
    Labeler DUNS
    282651413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-01
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2ee2efb3-5782-4ee4-a54c-8f614587c44d

    Device Description

    NOVAE Dual Mobility Acetabular Cup - CI E 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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

    GMDN Terms

    Code Name
    43168 Non-constrained polyethylene acetabular liner

    Identifiers

    Type ID
    Primary 03662200005925