BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sharn Inc

    DI: 00811571030873 · Model: S2020M · CLEAR IMAGE DEVICES LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sharn Inc
    Primary DI
    00811571030873
    Version / Model
    S2020M
    Catalog Number
    S2020-M
    Company Name
    CLEAR IMAGE DEVICES LLC
    Labeler DUNS
    115272845
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-20
    Public Version
    1
    Public Version Date
    2021-08-30
    Public Version Status
    New
    Public Device Record Key
    4b97a771-9e59-438e-914d-4f1f6c83f07b

    Device Description

    EyeGard Sensitive

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    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)

    GMDN Terms

    Code Name
    61490 Eye patch

    Identifiers

    Type ID
    Primary 00811571030873
    Previous 00817518022147