BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NuVasive Maximum Viscosity Spinal Cement System

    DI: 03760177047396 · Model: NuVasive Max. Visco. Cem. System · TEKNIMED
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NuVasive Maximum Viscosity Spinal Cement System
    Primary DI
    03760177047396
    Version / Model
    NuVasive Max. Visco. Cem. System
    Catalog Number
    10001127
    Company Name
    TEKNIMED
    Labeler DUNS
    764746723
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-23
    Public Version
    2
    Public Version Date
    2020-12-03
    Public Version Status
    Update
    Public Device Record Key
    f0a7f747-c01c-4d21-b577-cbf2e1c5cb7d

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NDN Cement, Bone, Vertebroplasty
    OAR Injector, Vertebroplasty (Does Not Contain Cement)
    JDZ Mixer, Cement, For Clinical Use

    GMDN Terms

    Code Name
    45253 Orthopaedic cement preparation/delivery kit

    Identifiers

    Type ID
    Primary 03760177047396

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 25 Degrees Celsius