BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Revita System

    Reg #: 3012744132 · FEI: 3012744132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FRACTYL HEALTH, INC.
    Registration Number
    3012744132
    FEI Number
    3012744132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Van de Graaff Drive, Suite 200
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Owner / Operator

    Firm Name
    Fractyl Health, Inc.
    Operator Number
    10057639
    Address
    3 Van de Graaff Drive, Suite 200
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US
    Correspondent
    Jonathan C Fitzgerald

    Products

    Device Name Product Code
    Device, Ultrasonic, Thermal Ablation MIK

    Proprietary Names

    Revita System

    Establishment Types

    Manufacture Device in the United States for Export Only