BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    The Q-GUIDE™ Electrode Insertion Tool

    DI: 00802526569401 · Model: 4710 · CAMERON HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    The Q-GUIDE™ Electrode Insertion Tool
    Primary DI
    00802526569401
    Version / Model
    4710
    Company Name
    CAMERON HEALTH, INC.
    Labeler DUNS
    017134557
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    f21154ce-69d0-4c22-bec2-18e5ac30d355

    Device Description

    Electrode Insertion Tool

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LWS Implantable cardioverter defibrillator (non-CRT)

    GMDN Terms

    Code Name
    32871 Surgical torque wrench, reusable

    Identifiers

    Type ID
    Primary 00802526569401

    Premarket Submissions

    Submission Number Supplement Number
    P110042 033
    P110042 039