BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CREO

    DI: 00889095495164 · Model: 6148.5000 · GLOBUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CREO
    Primary DI
    00889095495164
    Version / Model
    6148.5000
    Company Name
    GLOBUS MEDICAL, INC.
    Labeler DUNS
    139105691
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-31
    Public Version
    1
    Public Version Date
    2018-10-01
    Public Version Status
    New
    Public Device Record Key
    e2742926-1500-4d3a-83e3-fb5203e51f5d

    Device Description

    Locking Sleeve Inserter, T-Handle, CREO Side Loading

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
    NKB Thoracolumbosacral pedicle screw system
    KWQ Appliance, fixation, spinal intervertebral body

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 00889095495164

    Customer Contacts

    Phone
    +1(610)930-1800
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180210 000