BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mendec Spine

    DI: 28031497000101 · Model: 1230 · TECRES SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mendec Spine
    Primary DI
    28031497000101
    Version / Model
    1230
    Company Name
    TECRES SPA
    Labeler DUNS
    435428396
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-06
    Public Version
    3
    Public Version Date
    2020-06-19
    Public Version Status
    Update
    Public Device Record Key
    1c2e0d87-cfc4-49ef-b410-6e12cc944fa7

    Device Description

    Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application. The device is sold disposable and sterile

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NDN Cement, Bone, Vertebroplasty

    GMDN Terms

    Code Name
    35217 Orthopaedic cement, non-antimicrobial

    Identifiers

    Type ID
    Primary 28031497000101