HSA · registration DE0506947Covidien Tri-Staple™ 2.0 Reinforced Intelligent Reload
- Registration number
- DE0506947
- Model name
- Tri-Staple™ 2.0 Reinforced Intelligent Reload For use with Signia™ stapling system 45mm Medium/ Thick; Tri-Staple™ 2.0 Black Reinforced Intelligent Reload For use with Signia™ stapling system 45mm Extra Thick; Tri-Staple™ 2.0 Reinforced Intelligent Reload For use with Signia™ stapling system 60mm Medium/ Thick; Tri-Staple™ 2.0 Black Reinforced Intelligent Reload For use with Signia™ stapling system 60mm Extra Thick
- Model identifier
- SIGTRSB45AMT; SIGTRSB45AXT; SIGTRSB60AMT; SIGTRSB60AXT
- Registration date
- June 09, 2022
- Source update date
- January 08, 2026
- Risk class
- Class D
- Product owner
- Covidien llc
- Registrant / registration holder
- COVIDIEN PRIVATE LIMITED
Tri Staple™ 2.0 reinforced reloads preloaded with polyglycolic acid staple line reinforcement are indicated for use in abdominal and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The intended purpose of the device is transection and resection of tissue, and/or creation of anastomosis.
- Product owner address
- 15 Hampshire Street, Mansfield, MA 02048, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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.