BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    External Fixator Lengthening / compression tube small

    DI: 07640136270248 · Model: 1010-1100 · GEXFIX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    External Fixator Lengthening / compression tube small
    Primary DI
    07640136270248
    Version / Model
    1010-1100
    Company Name
    GEXFIX SA
    Labeler DUNS
    482579716
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    4
    Public Version Date
    2021-11-23
    Public Version Status
    Update
    Public Device Record Key
    50e4893a-0d32-4c71-8119-7b4ed229a01e

    Device Description

    Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

    GMDN Terms

    Code Name
    48011 External orthopaedic fixation system, single-use

    Identifiers

    Type ID
    Primary 07640136270248

    Premarket Submissions

    Submission Number Supplement Number
    K052605 000