BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AdaptDx Pro Eye Cups

    DI: 00850006785049 · Model: 10319 · MACULOGIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AdaptDx Pro Eye Cups
    Primary DI
    00850006785049
    Version / Model
    10319
    Company Name
    MACULOGIX, INC.
    Labeler DUNS
    962692179
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-09
    Public Version
    1
    Public Version Date
    2021-04-19
    Public Version Status
    New
    Public Device Record Key
    8d886904-9e7c-4bfb-9979-942edb3a1d96

    Device Description

    Left and right eye cups for the AdaptDx Pro headset.

    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HJW Adaptometer (Biophotometer)

    GMDN Terms

    Code Name
    10024 Adaptometer

    Identifiers

    Type ID
    Package 10850006785046
    Primary 00850006785049