BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LuxOR Revalia

    DI: 00380657530717 · Model: 00380657530717 · Alcon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LuxOR Revalia
    Primary DI
    00380657530717
    Version / Model
    00380657530717
    Company Name
    Alcon Laboratories, Inc.
    Labeler DUNS
    008018525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-28
    Public Version
    2
    Public Version Date
    2022-12-20
    Public Version Status
    Update
    Public Device Record Key
    fbd491cc-5600-430b-aab3-b98f41f3ec0e

    Device Description

    Surgical Microscope

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HRM MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

    GMDN Terms

    Code Name
    64676 Ophthalmic surgical microscope

    Identifiers

    Type ID
    Primary 00380657530717