BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NaviNetics Reusable Stereotactic Frame

    DI: 10850023620016 · Model: NN1100 · Navinetics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NaviNetics Reusable Stereotactic Frame
    Primary DI
    10850023620016
    Version / Model
    NN1100
    Company Name
    Navinetics, Inc.
    Labeler DUNS
    838320260
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-08
    Public Version
    1
    Public Version Date
    2022-11-16
    Public Version Status
    New
    Public Device Record Key
    fee1d0b1-712d-4545-b2dc-12d6384b14a8

    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
    Yes
    Has Manufacturing Date
    Yes
    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
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 10850023620016

    Premarket Submissions

    Submission Number Supplement Number
    K210700 000