BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioStar Transbronchial Aspiration Needle

    DI: 08565710078029 · Model: iS227 · BRONCUS MEDICAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioStar Transbronchial Aspiration Needle
    Primary DI
    08565710078029
    Version / Model
    iS227
    Company Name
    BRONCUS MEDICAL INC.
    Labeler DUNS
    078684808
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-19
    Public Version
    1
    Public Version Date
    2024-08-27
    Public Version Status
    New
    Public Device Record Key
    fe2c3caf-bd4d-4bf9-a809-56d727c9ce20

    Device Description

    The BioStar® Transbronchial Aspiration Needle is a sterile single-use disposable catheter with a coring needle in a protective sheath that directly connects to standard flexible optical bronchoscopes with a working channel of not less than 1.7 mm.

    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
    EOQ Bronchoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    38825 General-purpose endoscopic needle, single-use

    Identifiers

    Type ID
    Primary 08565710078029