BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cemex RX

    DI: 28031497000019 · Model: 1200/A · TECRES SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cemex RX
    Primary DI
    28031497000019
    Version / Model
    1200/A
    Company Name
    TECRES SPA
    Labeler DUNS
    435428396
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-08
    Public Version
    5
    Public Version Date
    2021-11-01
    Public Version Status
    Update
    Public Device Record Key
    f027b605-85c1-455a-98f7-b3f3cd365bea

    Device Description

    Cemex RX is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Cemex RX is indicated for the fixation of joint prosthesis implants to the host bone.

    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
    LOD Bone Cement

    GMDN Terms

    Code Name
    35217 Orthopaedic cement, non-antimicrobial

    Identifiers

    Type ID
    Primary 28031497000019