BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RTVue XR Avanti

    DI: 00858848006728 · Model: 100 · OPTOVUE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RTVue XR Avanti
    Primary DI
    00858848006728
    Version / Model
    100
    Catalog Number
    700-54345-001
    Company Name
    OPTOVUE, INC.
    Labeler DUNS
    196500461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-03
    Public Version
    2
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    1aa91591-ad16-4ec3-8005-c6b281a6f6bd

    Device Description

    Ophthalmic Optical Coherence Tomography System with 100/240V Table

    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 00858848006728

    Customer Contacts

    Phone
    866-941-9240
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K153080 000