BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gold Lens

    DI: 00855730007320 · Model: D101 · DIAGNOSYS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gold Lens
    Primary DI
    00855730007320
    Version / Model
    D101
    Catalog Number
    D101
    Company Name
    DIAGNOSYS LLC
    Labeler DUNS
    131488467
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-26
    Public Version
    1
    Public Version Date
    2021-05-04
    Public Version Status
    New
    Public Device Record Key
    0f127b02-e567-46d8-987c-122bb9bf8dc1

    Device Description

    Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HLZ Electrode, Corneal

    GMDN Terms

    Code Name
    11460 Electroretinograph electrode

    Identifiers

    Type ID
    Primary 00855730007320

    Premarket Submissions

    Submission Number Supplement Number
    K913239 000