BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    EV29L Sterile Biopsy Needle Guide

    Reg #: 3012402886 · FEI: 3012402886 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    EXACT IMAGING, INC.
    Registration Number
    3012402886
    FEI Number
    3012402886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7676 Woodbine Avenue, Unit 15
    City
    Markham Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K180636

    Owner / Operator

    Firm Name
    Exact Imaging, Inc.
    Operator Number
    10053728
    Address
    7676 Woodbine Avenue, Unit 15
    City
    Markham
    State
    Ontario
    Postal Code
    L3R 2N2
    Country
    CA
    Correspondent
    Randy AuCoin

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Biopsy Needle Guide Kit OIJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    EV29L Sterile Biopsy Needle Guide ExactVu™ High Resolution Micro-Ultrasound System EV29L High Resolution Transrectal Side-Fire Transducer EV29L Reusable Needle Guide EV9C Transrectal End-Fire Transducer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device