BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UNITY

    DI: 00380650003409 · Model: 00380650003409 · Alcon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    UNITY
    Primary DI
    00380650003409
    Version / Model
    00380650003409
    Catalog Number
    8065000340
    Company Name
    Alcon Laboratories, Inc.
    Labeler DUNS
    008018525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-03
    Public Version
    1
    Public Version Date
    2024-07-11
    Public Version Status
    New
    Public Device Record Key
    39ad20ff-8b34-4b4e-af79-e707825b6df6

    Device Description

    UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves

    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
    Yes
    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
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 10380650003406
    Primary 00380650003409