BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gynex

    DI: GYNX81001 · Model: 8100 · GYNEX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    12

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Gynex
    Primary DI
    GYNX81001
    Version / Model
    8100
    Company Name
    GYNEX CORPORATION
    Labeler DUNS
    012997685
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2023-12-19
    Public Version
    2
    Public Version Date
    2024-05-03
    Public Version Status
    Update
    Public Device Record Key
    d1de336d-1565-4a22-b4a6-3fdd1fed959b

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCZ Tube, Smoke Removal, Endoscopic

    GMDN Terms

    Code Name
    46483 Surgical plume evacuation system tube

    Identifiers

    Type ID
    Unit of Use GYNX81000
    Primary GYNX81001