Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010131578

FEI Number

3010131578

Entity Name

Gamma Centre of Excellence

City/State/Country

Laval Quebec, CA

Establishment Address

535 Cartier Boulevard Ouest, Laval Quebec H7V 3S8, CA

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Nordion Canada Inc. (Owner Number: 8022247)

Owner / Operator Contact Address

447 MARCH RD., --, OTTAWA, CA-ON K2K1X8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pin Kaps Puritan Fecal Opti-swab Collection and Transport System Puritan Liquid Amies Swab Collection and Transport System Exsalt CMC Gelling Fiber Dressing Clamp Covers; Vascular Silicone Ties Batrik Medical Manufacturing Inc Non-Sterile Cautery Tip Cleaner; Suture Clamp Tags Exsalt T7 Wound Dressing Fassier-Duval Telescopic IM System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-08-14
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2023-04-26
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2023-04-26
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2023-04-26
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2023-04-26
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2022-12-22
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2022-12-22
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2022-12-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-07-26
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2024-08-14
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2024-08-14
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-08-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-07-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-08-26

Official Correspondent

Natalie Girard

US Agent Details

Chris Eustace Business: Sterigenics Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Nordion Canada 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
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010131578. Last updated year: 2026. Please use registration number 3010131578 when referencing this establishment in official correspondence.