BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vertefix

    DI: 06009696221137 · Model: SP6540T · 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
    Primary DI
    06009696221137
    Version / Model
    SP6540T
    Catalog Number
    SP6540T
    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
    4
    Public Version Date
    2019-01-17
    Public Version Status
    Update
    Public Device Record Key
    6470700b-afb4-46ee-ab3f-d1ef94801273

    Device Description

    Mono Axial Pedicle Screw 6.5x40mm

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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 06009696221137