PRIMED MEDICAL PRODUCTS INC.

FDA Device Registration & Listing · Edmonton Alberta, CA · Registration 9615270

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615270
FEI Number
3002750002
Entity Name
PRIMED MEDICAL PRODUCTS INC.
City/State/Country
Edmonton Alberta, CA
Establishment Address
200, 2003 - 91 Street SW, Edmonton Alberta T6X0W8, CA
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
PRIMED Medical Products Inc. (Owner Number: 9030179)
Owner / Operator Contact Address
200, 2003 - 91 Street SW, EDMONTON, CA-AB T6X 0W8, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K160361
PMA Number
N/A

All Registered Proprietary Names

PRIMED Surgical Masks and PRIMED Procedure Masks PRIMED Sterilization Wrap PRIMED Sterilization Wrap

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OXZ Pediatric/Child Facemask General, Plastic Surgery Class 2 878.4040 2022-11-30
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2013-01-18
FME Gown, Examination General Hospital Class 1 880.6265 2006-02-17
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-08-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-04-29
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2002-01-09
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-08-27
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2008-07-09
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-12-13
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2000-12-12
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2024-11-27
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2016-11-07

Official Correspondent

Kam Ching

US Agent Details

Robert Duffy Business: Medical Device Post-Production Services Inc. Email: bob.duffy@mdpps-inc.com Phone: (858) 2318858

Related Public Records

Same Entity

PRIMED Medical Products Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013260641 priMED Jiujiang Medical Products Manufacturing Co., Ltd Jiujiang Jiangxi, CN
3017229009 PRIMED Medical Products Manufacturing Ltd. Cambridge Ontario, CA
3020755815 PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. Vientiane Capital Viangchan (Prefecture), LA
3005599545 PRIMED LIYANG MEDICAL PRODUCTS MANUFACTURING CO., LTD. Liyang Jiangsu, CN
3009540572 Gushi priMED Medical Products Manufacturing Co., Ltd. Gushi County Henan, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615270. Last updated year: 2026. Please use registration number 9615270 when referencing this establishment in official correspondence.
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