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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Regard

    DI: 00326053117749 · Model: GGLDSPUL-REG · RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Regard
    Primary DI
    00326053117749
    Version / Model
    GGLDSPUL-REG
    Company Name
    RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    Labeler DUNS
    134472476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-06
    Public Version
    1
    Public Version Date
    2020-08-14
    Public Version Status
    New
    Public Device Record Key
    e7be4c9d-4ba5-42fe-bd1d-2be56ab80a67

    Device Description

    Goggles Without Ventilation, Universal Size

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    No
    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)

    GMDN Terms

    Code Name
    58376 Eye splash shield, single-use

    Identifiers

    Type ID
    Package 10326053117746
    Primary 00326053117749