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HSA · registration DE0509510

Covidien Beacon™ Fine Needle Fiducial System

SingaporeGastroenterology & UrologyClass CCOVIDIEN LLC
Verified
Official record identity
Registration number
DE0509510
Model name
Beacon™ Fine Needle Fiducial System; Beacon™ Fine Needle Fiducial System; Beacon™ Fine Needle Fiducial Needle; Beacon™ Fine Needle Fiducial Needle
Model identifier
DSF-19-01; DSF-22-01; F-19-05; F-22-05
Registration date
July 10, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Gastroenterology & Urology
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Published parties
Product owner
COVIDIEN LLC
Registrant / registration holder
COVIDIEN PRIVATE LIMITED
Official description

The device is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark submucosal and extramural gastrointestinal lesions for future therapeutic procedures.

Additional source fields
Product owner address
15 Hampshire Street, Mansfield, Massachusetts, 02048, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.