BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TowerLOX EXT Cannulated Polyaxial EXT Screw 4.9 x 50mm

    DI: M7391613549500 · Model: 1613-4950 · CAPTIVA SPINE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TowerLOX EXT Cannulated Polyaxial EXT Screw 4.9 x 50mm
    Primary DI
    M7391613549500
    Version / Model
    1613-4950
    Company Name
    CAPTIVA SPINE, INC.
    Labeler DUNS
    836975784
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-02
    Public Version
    1
    Public Version Date
    2018-11-02
    Public Version Status
    New
    Public Device Record Key
    3c3a4852-2226-4563-b826-fd0f7faa72bc

    Device Description

    TowerLOX EXT Cannulated Polyaxial EXT Screw 4.9 x 50mm

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    NKB Thoracolumbosacral Pedicle Screw System

    GMDN Terms

    Code Name
    47554 Orthopaedic counter-torque/rod-pushing instrument

    Identifiers

    Type ID
    Primary M7391613549500

    Customer Contacts

    Phone
    5612779480
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180475 000