BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Emprint SX Table Top Field Generator (CAFG1)

    Reg #: 3008361498 · FEI: 3008361498 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Covidien
    Registration Number
    3008361498
    FEI Number
    3008361498
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2800 Airwest Blvd, Suite 160
    City
    Plainfield
    State
    IN
    ZIP
    46168
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171358

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    System, Ablation, Microwave And Accessories NEY

    Proprietary Names

    Emprint SX Table Top Field Generator (CAFG1) Emprint SX Long Navigation Antenna with Thermosphere Technology (CA30L3N) Emprint SX Ablation Platform (CASYS100) Emprint SX Short Navigation Antenna with Thermosphere Technology (CA15L2N) Emprint SX Laparoscopic Ultrasound Tracking Sensor (CAAL9150L) Emprint SX Table Top Field Generator Cart (CAFGCART1) Emprint SX Open Ultrasound Tracking Sensor (CABK8816) Emprint SX Open Ultrasound Tracking Sensor (CAAL9132) Emprint SX Laparoscopic Ultrasound Tracking Sensor (CABK8666L) Emprint SX Ultrasound Surgical Navigation (software) Application (CAUS1SN) Emprint SX Field Generator Spacers (Bed Pads) (CAFGSP1) Emprint Standard Navigation Antenna with Thermosphere Technology (CA20L2N)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)