BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Opti-Gard

    DI: 10850017419077 · Model: D28400 · DUPACO, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Opti-Gard
    Primary DI
    10850017419077
    Version / Model
    D28400
    Catalog Number
    D28400
    Company Name
    DUPACO, INC.
    Labeler DUNS
    093616555
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-10-30
    Public Version
    2
    Public Version Date
    2020-12-02
    Public Version Status
    Update
    Public Device Record Key
    d76be215-dc82-4427-ab11-a53567ecaf9e

    Device Description

    LASER OPTI-GARD LARGE NON-STERILE PACK

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HOY Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
    IWS Shield, eye, radiological

    GMDN Terms

    Code Name
    38884 Radiation shielding goggles/spectacles

    Identifiers

    Type ID
    Unit of Use 00850017419070
    Primary 10850017419077

    Customer Contacts

    Phone
    +1(760)758-4550
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    40 – 80 Degrees Fahrenheit