Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022247

FEI Number

3001092088

Entity Name

BWXT MEDICAL LTD.

City/State/Country

OTTAWA Ontario, CA

Establishment Address

447 MARCH RD., OTTAWA Ontario K2K1X8, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BWXT MEDICAL LTD. (Owner Number: 10061054)

Owner / Operator Contact Address

447 March Road, Mail Stn 7A, Ottawa, CA-ON K2K 1X8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TheraSphere Administration Accessory Kit TheraSphere Administration Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-11-15
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2024-11-15

Official Correspondent

Tapashi Dasgupta

US Agent Details

ALLY DANTA Business: PARAXEL INTERNATIONAL Email: US-Agent@parexel.com Phone: (978) 3132406

Related Public Records

Same Entity

BWXT MEDICAL LTD.

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
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

Similar Registrations

Registration Number	Establishment Name	Location
3000174892	CANADIAN SCIENTIFIC PRODUCTS LTD. DBA CSP MEDICAL	London Ontario, CA
3029900933	LEMER PAX AMERICA	Montreal Quebec, CA
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3005257704	BEIJING KELIDA MEDICAL EQUIPMENT DEVELOPING CO., LTD	Beijing City, CN
3016948452	QINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO., LTD	Qinhuangdao Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022247. Last updated year: 2026. Please use registration number 8022247 when referencing this establishment in official correspondence.