BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Post Op Spectacle Fitover, Clear

    DI: 00818806020364 · Model: 62012-004 · RXSIGHT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Post Op Spectacle Fitover, Clear
    Primary DI
    00818806020364
    Version / Model
    62012-004
    Company Name
    RXSIGHT, INC.
    Labeler DUNS
    052054413
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-08
    Public Version
    3
    Public Version Date
    2023-05-02
    Public Version Status
    Update
    Public Device Record Key
    be69f2a5-b4f5-4e18-9d6c-e956f35a21ed
    Distribution End Date
    2023-05-01

    Device Description

    Post Op Spectacle Fitover, Clear, Large

    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQY Sunglasses (Non-Prescription Including Photosensitive)

    GMDN Terms

    Code Name
    46297 Tinted non-prescription spectacle lens

    Identifiers

    Type ID
    Primary 00818806020364