BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AOS Implant Needle, Series-17, 15 cm, 14°

    DI: 00850645007052 · Model: NID0001-007 · ALPHA-OMEGA SERVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    AOS Implant Needle, Series-17, 15 cm, 14°
    Primary DI
    00850645007052
    Version / Model
    NID0001-007
    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
    4701e2be-7fdb-4ff7-8b25-e3a3294462d7

    Device Description

    Needle, Implant, Series-17, 15 cm, 14°, 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
    ["Moist Heat or Steam Sterilization", "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 00850645007052
    Unit of Use 00850645007649