BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NeuroNav Pelican Case

    DI: 27290114063702 · Model: NeuroNav Pelican Case · ALPHA OMEGA ENGINEERING CO. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NeuroNav Pelican Case
    Primary DI
    27290114063702
    Version / Model
    NeuroNav Pelican Case
    Catalog Number
    700-000888-00
    Company Name
    ALPHA OMEGA ENGINEERING CO. LTD.
    Labeler DUNS
    531856466
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-14
    Public Version
    1
    Public Version Date
    2023-05-22
    Public Version Status
    New
    Public Device Record Key
    38bd297b-899f-4169-ae42-2a9f40599df3

    Device Characteristics

    Single Use
    No
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GZL Electrode, Depth

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 27290114063702

    Premarket Submissions

    Submission Number Supplement Number
    K172042 000