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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMA Optics Occluder

    DI: G506OCCLM0 · Model: O-MAGNETIC · AMA Optics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AMA Optics Occluder
    Primary DI
    G506OCCLM0
    Version / Model
    O-MAGNETIC
    Catalog Number
    OCCLM
    Company Name
    AMA Optics, Inc.
    Labeler DUNS
    192827462
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-01
    Public Version
    1
    Public Version Date
    2023-08-09
    Public Version Status
    New
    Public Device Record Key
    63adffc2-1673-4d1a-a0be-888b5143025f

    Device Description

    A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.

    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
    HPC Set, Lens, Trial, Ophthalmic

    GMDN Terms

    Code Name
    37337 Ocular occluder/Maddox rod

    Identifiers

    Type ID
    Primary G506OCCLM0