BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LENSX

    DI: 10380650000535 · Model: 8065000053 · Alcon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    LENSX
    Primary DI
    10380650000535
    Version / Model
    8065000053
    Company Name
    Alcon Laboratories, Inc.
    Labeler DUNS
    008018525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-11-04
    Public Version
    3
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    bbadb1f2-3f80-4171-a3c8-b477ca20f37f

    Device Description

    LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQC Unit, phacofragmentation

    GMDN Terms

    Code Name
    65747 Ophthalmic laser system eyeball positioning suction cup

    Identifiers

    Type ID
    Primary 10380650000535
    Unit of Use 00380650000538
    Package 20380650000532