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    FDA UDI In Commercial Distribution 🇺🇸 United States

    GMReis Fibula Nail System

    DI: 07899258695112 · Model: Right Fibula Nail 3,0x145mm · GM DOS REIS INDUSTRIA E COMERCIO LTDA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GMReis Fibula Nail System
    Primary DI
    07899258695112
    Version / Model
    Right Fibula Nail 3,0x145mm
    Catalog Number
    302-08US
    Company Name
    GM DOS REIS INDUSTRIA E COMERCIO LTDA
    Labeler DUNS
    900865213
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-24
    Public Version
    2
    Public Version Date
    2025-12-08
    Public Version Status
    Update
    Public Device Record Key
    f08b72a9-9682-487a-9aa1-2216b91335cb

    Device Description

    Right Fibula Nail 3,0x145mm

    Device Characteristics

    Single Use
    Yes
    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
    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
    HSB Rod, Fixation, Intramedullary And Accessories

    GMDN Terms

    Code Name
    44854 Arthrodesis intramedullary nail, non-distracting

    Identifiers

    Type ID
    Primary 07899258695112