BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Argus II Operating Room Coil

    DI: 00850052743161 · Model: 012103-003 · CORTIGENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Argus II Operating Room Coil
    Primary DI
    00850052743161
    Version / Model
    012103-003
    Catalog Number
    012103
    Company Name
    CORTIGENT, INC.
    Labeler DUNS
    118946135
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    b86675fd-0736-4949-85c0-839bfdeb46a8

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    Yes
    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
    NBF Prosthesis, Retinal

    GMDN Terms

    Code Name
    58524 Retinal prosthesis system tester/clinical evaluator

    Identifiers

    Type ID
    Primary 00850052743161
    Previous 00856264005387

    Customer Contacts

    Phone
    18188335027
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    H110002 003

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    32 – 113 Degrees Fahrenheit