EPIMED INTERNATIONAL, INC.

Reg #: 1316297 · FEI: 1316297 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: EPIMED INTERNATIONAL, INC.
Registration Number: 1316297
FEI Number: 1316297
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 141 SAL LANDRIO DR., CROSSROADS BUSINESS PARK
City: JOHNSTOWN
State: NY
ZIP: 12095
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	Device Class	Medical Specialty	Exempt	Created
Generator, Lesion, Radiofrequency	GXD	Class 2	Neurology	No	2024-08-19
Probe, Radiofrequency Lesion	GXI	Class 2	Neurology	No	2008-04-16
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	Class 2	Anesthesiology	No	2008-04-16
Needle, Spinal, Short Term	MIA	Class 2	Anesthesiology	No	2020-05-19
Catheter, Conduction, Anesthetic	BSO	Class 2	Anesthesiology	No	2020-05-19
Device, Surgical, Cryogenic	GXH	Class 2	Neurology	No	2013-04-24
Set, Administration, Intravascular	FPA	Class 2	General Hospital	No	2008-04-16
Probe, Lachrymal	HNL	Class 1	Ophthalmic	No	2014-01-20
Marker, Cardiopulmonary Bypass (Vein Marker)	MAB	Class 2	Cardiovascular	No	2014-01-21
Adaptor, Catheter	GCE	Class 1	General, Plastic Surgery	No	1992-07-27
Anesthesia Conduction Kit	CAZ	Class 2	Anesthesiology	No	2008-04-16

Proprietary Names

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

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)