BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DTL

    DI: 00850594007011 · Model: D141 · DIAGNOSYS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DTL
    Primary DI
    00850594007011
    Version / Model
    D141
    Catalog Number
    D141
    Company Name
    DIAGNOSYS LLC
    Labeler DUNS
    131488467
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-29
    Public Version
    4
    Public Version Date
    2023-06-27
    Public Version Status
    Update
    Public Device Record Key
    eaa5e00b-c42d-47f7-b64b-90e983ecec7e

    Device Description

    A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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 00850594007011