Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009823392

FEI Number

3009823392

Entity Name

EIRMED, LLC

City/State/Country

Menomonie, WI, US

Establishment Address

5120 Eagle Point Rd, Menomonie, WI 54751, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

EirMed, LLC (Owner Number: 10051379)

Owner / Operator Contact Address

5120 Eagle Point Road, Menomonie, WI 54751, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2024-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EirMed, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

Similar Registrations

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3010034260	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Santa Rosa, CA, US
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
9680425	Avent S. de R.L. de C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009823392. Last updated year: 2026. Please use registration number 3009823392 when referencing this establishment in official correspondence.