BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORA System® VerifEye™

    DI: 00380657529995 · Model: 8065752999 · Alcon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORA System® VerifEye™
    Primary DI
    00380657529995
    Version / Model
    8065752999
    Company Name
    Alcon Laboratories, Inc.
    Labeler DUNS
    008018525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-31
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    22efaac9-a852-4027-9d29-2edb5116cc32

    Device Description

    ORA System with VerifEyeTM Lynk, Aberrometer 184.5

    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
    NCF Aberrometer, ophthalmic

    GMDN Terms

    Code Name
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 00380657529995

    Customer Contacts

    Phone
    +1(800)862-5266
    Email
    [email protected]