BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Racz Neurostat RF Generator

    Reg #: 1643059 · FEI: 1643059 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Epimed International, Inc.
    Registration Number
    1643059
    FEI Number
    1643059
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13958 Diplomat Drive
    City
    Dallas
    State
    TX
    ZIP
    75234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232632

    Owner / Operator

    Firm Name
    Epimed International, Inc.
    Operator Number
    1316297
    Address
    141 SAL LANDRIO DR., CROSSROADS BUSINESS PARK
    City
    Johnstown
    State
    NY
    Postal Code
    12095
    Country
    US

    Products

    Device Name Product Code
    Generator, Lesion, Radiofrequency GXD

    Proprietary Names

    Racz Neurostat RF Generator

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility