BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AdaptDx Pro Head Strap

    DI: 00850006785063 · Model: HS-1 · MACULOGIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AdaptDx Pro Head Strap
    Primary DI
    00850006785063
    Version / Model
    HS-1
    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
    2
    Public Version Date
    2021-12-14
    Public Version Status
    Update
    Public Device Record Key
    6fd0411f-04ee-4f9f-bfa9-fbc83a44686a

    Device Description

    Head strap for the AdaptDx Pro

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OUM Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

    GMDN Terms

    Code Name
    10024 Adaptometer

    Identifiers

    Type ID
    Package 10850006785060
    Primary 00850006785063
    Package 20850006785067