Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2134604

FEI Number

3002623849

Entity Name

JunoPacific, Inc.

City/State/Country

Brooklyn Park, MN, US

Establishment Address

8701 95th Avenue North, Brooklyn Park, MN 55445, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JUNOPACIFIC INC. (Owner Number: 9036368)

Owner / Operator Contact Address

8701 95th Avenue North, --, Brooklyn Park, MN 55445, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Connector Tool Confirm Rx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2022-11-21
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2022-11-21
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2021-02-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2024-03-25

Official Correspondent

Brian Gaeth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JUNOPACIFIC INC.

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
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Similar Registrations

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3009380063	Medtronic Distribution Center	Memphis, TN, US
2124215	Boston Scientific Corporation	Saint Paul, MN, US
1000121056	Boston Scientific Corporation	Coventry, RI, US
2648729	Boston Scientific Corporation	Dorado, PR, US
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134604. Last updated year: 2026. Please use registration number 2134604 when referencing this establishment in official correspondence.