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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Compass International

    DI: B169DBNP1010TP0 · Model: DBNP-10-10TP · Compass International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Compass International
    Primary DI
    B169DBNP1010TP0
    Version / Model
    DBNP-10-10TP
    Catalog Number
    DBNP-10-10TP
    Company Name
    Compass International
    Labeler DUNS
    809466410
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-13
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    db873b8d-16ff-483d-80f7-e61682cfe896

    Device Description

    Cygnus-PFS TracPlus Disposable Biopsy Needle

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GAA Needle, Aspiration And Injection, Disposable

    GMDN Terms

    Code Name
    47540 Soft-tissue biopsy needle, single-use

    Identifiers

    Type ID
    Primary B169DBNP1010TP0