BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PAJUNK MEDICAL SYSTEMS

    Reg #: 3004076349 · FEI: 3004076349 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    PAJUNK MEDICAL SYSTEMS
    Registration Number
    3004076349
    FEI Number
    3004076349
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4575 Marconi Dr.
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243690

    Owner / Operator

    Firm Name
    PAJUNK GmbH Medizintechnologie
    Operator Number
    8010639
    Address
    Karl-Hall-Strasse 1
    City
    Geisingen
    State
    Baden-Wurttemberg
    Postal Code
    78187
    Country
    DE

    Products

    Device Name Product Code
    Spinal Anesthesia Kit OFU
    Nerve Block Tray OGJ
    Instrument, Surgical, Disposable KDC
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Custom Anesthesia Tray OGD
    Stimulator, Neuromuscular, External Functional GZI
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Device, Biofeedback HCC
    Epidural Anesthesia Kit OGE

    Proprietary Names

    SPROTTE NRFit Kit Spinal anesthesia kit Nerve Block Tray Injection tube, anesthetic agent Sono MSK SPROTTE® NRFit kit EpiLong Soft NRFit Stim2Go Epidural anesthesia kit SonoBlock SonoBlock II Facet SonoBlock II Facet NRFit SonoBlock II Facet S

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198