BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Optimum Extreme

    DI: 00865576000218 · Model: roflufocon E · CONTAMAC HOLDINGS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Optimum Extreme
    Primary DI
    00865576000218
    Version / Model
    roflufocon E
    Catalog Number
    roflufocon E
    Company Name
    CONTAMAC HOLDINGS LIMITED
    Labeler DUNS
    216236887
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-22
    Public Version
    2
    Public Version Date
    2023-06-13
    Public Version Status
    Update
    Public Device Record Key
    13fe7ea2-2dfc-4e6a-947d-ab9ad151bf03

    Device Description

    Rigid Gas Permeable Contact Lens

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQD Lens, Contact (Other Material) - Daily
    MUW Lens, Contact (Orthokeratology)

    GMDN Terms

    Code Name
    47840 Rigid-gas-permeable corrective contact lens, daily-wear

    Identifiers

    Type ID
    Primary 00865576000218

    Premarket Submissions

    Submission Number Supplement Number
    K033594 000
    K160859 000
    K161100 000
    K180616 000