Sirtex Wilmington LLC

FDA Device Registration & Listing · Wilmington, MA, US · Registration 3005579300

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
3005579300
FEI Number
3005579300
Entity Name
Sirtex Wilmington LLC
City/State/Country
Wilmington, MA, US
Establishment Address
16 Upton Drive Unit 2-4, Wilmington, MA 01887, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Sirtex Medical Inc. (Owner Number: 9047689)
Owner / Operator Contact Address
300 Unicorn Park Dr., 2nd Fl., Woburn, MA 01801, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SIR-Spheres Delivery Box SIROS Delivery Dome SIR-Spheres SIR-Spheres Select Y-90 resin microspheres SIR-Spheres Select SIR-Spheres microspheres Syringe Shield

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2003-12-19
NAW Microspheres Radionuclide Unknown Class 3 N/A 2007-10-23
IWR Holder, Syringe, Lead Radiology Class 1 892.6500 2003-12-19

Official Correspondent

Jeffrey Cyr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sirtex Medical 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
3013070673 Sirtex Germany Manufacturing GmbH Frankfurt am Main Hesse, DE
3009088444 Sirtex Singapore Manufacturing Pte Ltd Singapore Central Singapore, SG
3012690638 SIRTEX MEDICAL INC. Woburn, MA, US

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 3005579300. Last updated year: 2026. Please use registration number 3005579300 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.