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    FDA UDI In Commercial Distribution 🇺🇸 United States

    RTVue XR Avanti Scanner

    DI: 00858848006667 · Model: Avanti Scanner · OPTOVUE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RTVue XR Avanti Scanner
    Primary DI
    00858848006667
    Version / Model
    Avanti Scanner
    Catalog Number
    500-50845-003
    Company Name
    OPTOVUE, INC.
    Labeler DUNS
    196500461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-12
    Public Version
    2
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    5f3f018d-2a13-428c-8ae4-c6a383a1762b

    Device Description

    For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System

    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
    HLI Ophthalmoscope, Ac-Powered
    OBO Tomography, Optical Coherence

    GMDN Terms

    Code Name
    58850 Ophthalmic spectral-domain optical coherence tomography system

    Identifiers

    Type ID
    Primary 00858848006667

    Customer Contacts

    Phone
    866-941-9240
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K153080 000