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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Compass International

    DI: B169REG30020 · Model: REG-3002 · Compass International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Compass International
    Primary DI
    B169REG30020
    Version / Model
    REG-3002
    Catalog Number
    REG-3002
    Company Name
    Compass International
    Labeler DUNS
    809466410
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-26
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    c9073097-0e12-4139-8b8e-8f02da086487

    Device Description

    Radiographic Markers - Large Disc

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    47020 Imaging lesion localization marker, external, single-use

    Identifiers

    Type ID
    Primary B169REG30020