BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CosmoLock Pedicle Screw System

    DI: B07310NBN04500 · Model: 10-NBN-0450 · Kalitec Direct LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CosmoLock Pedicle Screw System
    Primary DI
    B07310NBN04500
    Version / Model
    10-NBN-0450
    Company Name
    Kalitec Direct LLC
    Labeler DUNS
    041956211
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-14
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    18e2ab33-05db-47fc-91af-926423afcab5

    Device Description

    Guidewire, NiTi Blunt Non-threaded, 450mm

    Device Characteristics

    Single Use
    Yes
    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
    GDF Guide, Needle, Surgical

    GMDN Terms

    Code Name
    46165 Orthopaedic guidewire, reusable

    Identifiers

    Type ID
    Primary B07310NBN04500