BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AOS Flexiguide Needle

    DI: 00850645007342 · Model: NFV0003-003 · ALPHA-OMEGA SERVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    AOS Flexiguide Needle
    Primary DI
    00850645007342
    Version / Model
    NFV0003-003
    Company Name
    ALPHA-OMEGA SERVICES, INC.
    Labeler DUNS
    060398989
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-10-05
    Public Version
    4
    Public Version Date
    2019-02-07
    Public Version Status
    Update
    Public Device Record Key
    3347033f-bb9d-46cb-bd55-26bd6d136669

    Device Description

    Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 20 cm, 10 ea

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    JAQ System, Applicator, Radionuclide, Remote-Controlled

    GMDN Terms

    Code Name
    38436 General-purpose brachytherapy system applicator, remote-afterloading

    Identifiers

    Type ID
    Primary 00850645007342
    Unit of Use 00850645007816