BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COMPASS CYGNUS-PFS IGS System

    DI: 00860009258105 · Model: CYG-PFSN-10TP · Compass International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COMPASS CYGNUS-PFS IGS System
    Primary DI
    00860009258105
    Version / Model
    CYG-PFSN-10TP
    Catalog Number
    CYG-PFSN-10TP
    Company Name
    Compass International
    Labeler DUNS
    809466410
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-29
    Public Version
    1
    Public Version Date
    2026-02-06
    Public Version Status
    New
    Public Device Record Key
    d000f146-143f-400d-933e-cc07cf88caae

    Device Description

    COMPASS CYGNUS-PFS Image Guide System

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    No
    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
    Ethylene Oxide, Hydrogen Peroxide, Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 00860009258105

    Premarket Submissions

    Submission Number Supplement Number
    K964229 000