BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Guide Needle

    DI: M936BGNS0 · Model: BGNS · ISOAID, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Guide Needle
    Primary DI
    M936BGNS0
    Version / Model
    BGNS
    Company Name
    ISOAID, L.L.C.
    Labeler DUNS
    002751241
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-02-04
    Public Version
    8
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    c9492d0a-58b2-45ed-add5-a37e295e10eb

    Device Description

    Brachytherapy Guide Needle

    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
    Yes
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    HXK Holder, Needle; Orthopedic

    GMDN Terms

    Code Name
    45018 Needle guide, single-use

    Identifiers

    Type ID
    Primary M936BGNS0