BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Epimed International, Inc.

    Reg #: 1643059 · FEI: 1643059 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    Epimed International, Inc.
    Registration Number
    1643059
    FEI Number
    1643059
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13958 Diplomat Drive
    City
    Dallas
    State
    TX
    ZIP
    75234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022029

    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
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Catheter, Conduction, Anesthetic BSO
    Probe, Radiofrequency Lesion GXI
    Generator, Lesion, Radiofrequency GXD
    Device, Surgical, Cryogenic GXH
    Set, Administration, Intravascular FPA
    Adaptor, Catheter GCE
    Anesthesia Conduction Kit CAZ
    Needle, Spinal, Short Term MIA

    Proprietary Names

    Chiba Needle Quincke Spinal Needle Spirol Block Catheter R-F Cannula RX Epidural Needle Tuohy Epidural Needle RULO™ Radiofrequency Lesion Probe Racz Neurostat RF Generator RK Epidural Introducer Needle Day Needle Blunt Nerve Block Needle PainBlocker Extension Set Wiley Spinal Spirol Epidural Catheter Feth-R-Kath Tun-L-XL Tun-L-Kath Brevi STF Brevi-XL E-Kath Brevi-Kath Racz Epidural Catheter Catheter Connector Versa-Kath Nexus Catheter Connector Stingray Epidural Cath. Connector Peelaway Introducer Needle Blunt Access Cannula Flexible Introducer Cannula Percutaneous Introducer

    Establishment Types

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