Singapore HSA registration DE0504962
Covidien Tri-Staple™ 2.0 Intelligent Reloads
Singapore·CLASS D·Covidien IIc·Registered September 23, 2020Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0504962
- Registration Date
- September 23, 2020
- Change Notification Approval Date
- March 14, 2025
- Retention Due Date
- September 22, 2025
Product description
The Tri‑Staple™ 2.0 reloads are indicated for use in abdominal and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The Tri‑Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue. The intended purpose of the device is transection and resection of tissue, and/or creation of anastomosis.
Product Owner
- Name
- Covidien IIc
- Short Name
- Covidien IIc
- Address
- 15 Hampshire Street,, Mansfield, MA02048, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- Tri-Staple™ 2.0 Intelligent Reload 30mm Medium/Thick Tri-Staple™ 2.0 Gray Intelligent Reload 30mm Extra Thin/Vascular Tri-Staple™ 2.0 Intelligent Reload 30mm Vascular/Medium Tri-Staple™ 2.0 Gray Curved Tip Intelligent Reload 30mm Extra Thin/Vascular Tri-Staple™ 2.0 Curved Tip Intelligent Reload 30mm Vascular/Medium Tri-Staple™ 2.0 Black Intelligent Reload 45mm Extra Thick Tri-Staple™ 2.0 Curved Tip Intelligent Reload 60mm Medium/Thick Tri-Staple™ 2.0 Gray Curved Tip Intelligent Reload 45mm Extra Thin/Vascular Tri-Staple™ 2.0 Curved Tip Intelligent Reload 45mm Vascular/Medium Tri-Staple™ 2.0 Black Intelligent Reload 60mm Extra Thick Tri-Staple™ 2.0 Curved Tip Intelligent Reload 60mm Medium/Thick Tri-Staple™ 2.0 Curved Tip Intelligent Reload 60mm Vascular/Medium
- Model Identifier(s)
- SIG30AMT SIG30AV SIG30AVM SIG30CTAV SIG30CTAVM SIG45AXT SIG45CTAMT SIG45CTAV SIG45CTAVM SIG60AXT SIG60CTAMT SIG60CTAVM
About this record
Access comprehensive regulatory information for Covidien Tri-Staple™ 2.0 Intelligent Reloads in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504962 and owned by Covidien IIc. The device was registered on September 23, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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