BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZonedIn Contact Lenses

    DI: 00810040144325 · Model: SH1250BO · ZONEDIN VISION, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    ZonedIn Contact Lenses
    Primary DI
    00810040144325
    Version / Model
    SH1250BO
    Catalog Number
    SH1250BO
    Company Name
    ZONEDIN VISION, LLC
    Labeler DUNS
    117142079
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2020-03-05
    Public Version
    1
    Public Version Date
    2020-03-13
    Public Version Status
    New
    Public Device Record Key
    c91fb341-ffd2-4c2f-8dd4-cfad0bdfbe14

    Device Description

    Silicone hydrogel Daily wear soft contact lens power +2.50 (boxes)

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVN Lens, contact, (disposable)
    LPL Lenses, soft contact, daily wear

    GMDN Terms

    Code Name
    47841 Soft corrective contact lens, daily-disposable

    Identifiers

    Type ID
    Unit of Use 00810040144141
    Primary 00810040144325