BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WRI-1

    DI: 00628678036055 · Model: 01 · Cellview Imaging Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WRI-1
    Primary DI
    00628678036055
    Version / Model
    01
    Company Name
    Cellview Imaging Inc.
    Labeler DUNS
    203780184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-08
    Public Version
    1
    Public Version Date
    2022-09-16
    Public Version Status
    New
    Public Device Record Key
    00d5dfa9-dd80-4840-83a8-6f9a7be117bd

    Device Description

    The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye.

    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
    Yes
    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
    PJZ Camera, Ophthalmic, General-Use

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 00628678036055