BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPECTRA Disposable Radio Frequency (RF) Needle

    Reg #: 1224960 · FEI: 3000204727 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SPECTRA MEDICAL DEVICES, LLC
    Registration Number
    1224960
    FEI Number
    3000204727
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    299 Ballardvale St Ste 1
    City
    WILMINGTON
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032196

    Owner / Operator

    Firm Name
    SPECTRA MEDICAL DEVICES, LLC
    Operator Number
    9012618
    Address
    299 BALLARDVALE STREET, SUITE 1
    City
    Wilmington
    State
    MA
    Postal Code
    01887
    Country
    US

    Products

    Device Name Product Code
    Probe, Radiofrequency Lesion GXI
    Generator, Lesion, Radiofrequency GXD

    Proprietary Names

    SPECTRA Disposable Radio Frequency (RF) Needle NBD Disposable RF Cannula

    Establishment Types

    Manufacture Medical Device