BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SIros Navigated Instruments

    DI: M719GSI243LGA0 · Model: 1 · Genesys Orthopedics Systems LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SIros Navigated Instruments
    Primary DI
    M719GSI243LGA0
    Version / Model
    1
    Catalog Number
    GSI243-LG-A
    Company Name
    Genesys Orthopedics Systems LLC
    Labeler DUNS
    017921066
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-01
    Public Version
    1
    Public Version Date
    2024-04-09
    Public Version Status
    New
    Public Device Record Key
    8713a4ec-a736-4327-8166-9b25876112ab

    Device Description

    SI Navigated Spiked Large Drill Guide - Angeled Tip Assembly

    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
    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

    Product Codes

    Code Name
    OUR Sacroiliac Joint Fixation

    GMDN Terms

    Code Name
    58849 Sacroiliac joint transarticular fixation/arthrodesis implantation kit

    Identifiers

    Type ID
    Primary M719GSI243LGA0

    Customer Contacts

    Phone
    5123817070
    Email
    [email protected]