Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680488

FEI Number

3002642300

Entity Name

PRIMED INSTRUMENTS, INC.

City/State/Country

MISSISSAUGA Ontario, CA

Establishment Address

1080 TRISTAR DR., UNIT 11, 13 & 14, MISSISSAUGA Ontario L5T 1P1, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

PRIMED INSTRUMENTS, INC. (Owner Number: 9009402)

Owner / Operator Contact Address

1080 TRISTAR DR., UNIT 14, --, MISSISSAUGA, ONTARIO, CA-NOTA L5T 1P1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single Use Grasping Forceps Single Use Retrieval Device Baron Suction Tube Brush Double-Ended Cleanable Brush Blue Stiff-Line Cleaning Brush Double-Ended Valve Brush Large Cleaning Brush Instrument Cleaning Brush Single-Ended Cleanable Brush Single-Ended Valve Brush Large Instrument Brush Frazier Suction Tube Brush Double-Ended (Acetabular) Reamer Brush Cannula Cleaning Brush Cleaning Brush Double-Ended Cleaning Brush Nylon Twisted Wire Cleaning Brush SuperDART® Pull Through Channel Cleaning Device with Squeegee Wiper DART® Endoscope Channel Cleaning Brush Disposable Channel Brushes Reusable Channel Brushes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2017-08-25
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2019-12-09
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2004-10-04

Official Correspondent

JACK KRZYZANOWSKI

US Agent Details

Katie Doane Business: TOBIAS SYSTEM, LLC Email: katie@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

PRIMED INSTRUMENTS, INC.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3015972835	HEINRICH MEDIZINTECHNIK GMBH	Stuttgart Baden-Wurttemberg, DE
1061927	INTERNATIONAL STERILIZATION LABORATORY, LLC	GROVELAND, FL, US
3013460719	ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.	Hangzhou Zhejiang, CN
3036978610	Zhuhai Pusen Medical Technology Co., Ltd.	Zhuhai Guangdong, CN
3015972753	STERISERVICE SP. Z O.O.	Czestochowa Slaskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680488. Last updated year: 2026. Please use registration number 9680488 when referencing this establishment in official correspondence.