BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Wave Light FS200 EASYPACK

    DI: 00380650004529 · Model: 1515 · Alcon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    Wave Light FS200 EASYPACK
    Primary DI
    00380650004529
    Version / Model
    1515
    Catalog Number
    8065000452
    Company Name
    Alcon Laboratories, Inc.
    Labeler DUNS
    008018525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2025-11-20
    Public Version
    1
    Public Version Date
    2025-11-28
    Public Version Status
    New
    Public Device Record Key
    5241263c-b94f-455a-bc82-7fb9e603ad98

    Device Description

    WaveLight FS200 EASYPACK Patient Interface (BOX OF 20)

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument
    HNO Keratome, Ac-Powered

    GMDN Terms

    Code Name
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00380650004529
    Unit of Use 50380650004531