BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Leksell Stereotactic System

    DI: 07340201503263 · Model: 1040455 · Elekta Solutions AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Leksell Stereotactic System
    Primary DI
    07340201503263
    Version / Model
    1040455
    Catalog Number
    1040318
    Company Name
    Elekta Solutions AB
    Labeler DUNS
    353272181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-03
    Public Version
    2
    Public Version Date
    2025-09-18
    Public Version Status
    Update
    Public Device Record Key
    31d4eb96-d93f-411d-87e2-351f201adfa6

    Device Description

    Leksell Coordinate Frame G - POSTERIOR MEMBER

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 07340201503263

    Premarket Submissions

    Submission Number Supplement Number
    K152558 000