Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011743372

FEI Number

3011743372

Entity Name

GMI CORPORATION

City/State/Country

Franklin, IN, US

Establishment Address

700 International Dr, Franklin, IN 46131, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GMI Corporation (Owner Number: 10052677)

Owner / Operator Contact Address

700 International Drive, Franklin, IN 46131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Masimo Bridge, NSS-2 BRIDGE NICO BrainPath IB-Stim Electro Auricular Device NICO TRIOwand

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PZR	Percutaneous Nerve Stimulator For Opioid Withdrawal	Neurology	Class 2	882.5896	2021-02-05
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2017-11-09
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2021-11-11
QHH	Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)	Gastroenterology, Urology	Class 2	876.5340	2020-11-10
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2020-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-09

Official Correspondent

Aaron Barr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GMI Corporation

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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3010350335	Neurostimulation Medtech Private Limited	Chennai Tamil Nadu, IN
3008255748	HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.	La Mesa, Tijuana Baja California, MX
3017987352	Spark Biomedical Inc.	Richmond, TX, US
3014122529	Velentium Medical	Richmond, TX, US
3039168176	NET RECOVERY CORP	Costa Mesa, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011743372. Last updated year: 2026. Please use registration number 3011743372 when referencing this establishment in official correspondence.