BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-ICG 4mm Sinuscope (30 Deg)

    DI: G465FG14000 · Model: FG-14 · Smartsurgn Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Non-ICG 4mm Sinuscope (30 Deg)
    Primary DI
    G465FG14000
    Version / Model
    FG-14
    Company Name
    Smartsurgn Inc.
    Labeler DUNS
    115617378
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-27
    Public Version
    1
    Public Version Date
    2025-09-04
    Public Version Status
    New
    Public Device Record Key
    86f3464d-0077-4c5b-88e7-28f01cafc1ae

    Device Description

    Non-ICG 4mm Sinuscope (30 Deg)

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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

    Product Codes

    Code Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    37180 Rigid optical sinoscope

    Identifiers

    Type ID
    Primary G465FG14000

    Premarket Submissions

    Submission Number Supplement Number
    K032822 000