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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vertefix II

    DI: 06009696227320 · Model: CZE7535MX · ELITE SURGICAL SUPPLIES (PTY) LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vertefix II
    Primary DI
    06009696227320
    Version / Model
    CZE7535MX
    Catalog Number
    CZE7535MX
    Company Name
    ELITE SURGICAL SUPPLIES (PTY) LTD
    Labeler DUNS
    568359710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-04-25
    Public Version Status
    Update
    Public Device Record Key
    0149c90c-47a1-424d-820f-5e4cebae9411

    Device Description

    Vertefix II Multi-Axial Extension Screw 7.5 x 35mm

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MNH Orthosis, Spondylolisthesis Spinal Fixation
    MNI Orthosis, Spinal Pedicle Fixation

    GMDN Terms

    Code Name
    37272 Trans-facet-screw internal spinal fixation system, sterile

    Identifiers

    Type ID
    Primary 06009696227320