HSA · registration DE0509518Covidien VersaOne™ Optical Trocar with Fixation Balloon Cannula
- Registration number
- DE0509518
- Model name
- VersaOne™ optical trocar with fixation balloon cannula 5mm long; VersaOne™ optical trocar with fixation balloon cannula 5mm short; VersaOne™ optical trocar with fixation balloon cannula 5mm standard; VersaOne™ universal cannula fixation balloon 5mm standard
- Model identifier
- ONB5LGB; ONB5SHB; ONB5STB; UNVCA5STB
- Registration date
- July 12, 2024
- Risk class
- Class B
- Product owner
- Covidien llc
- Registrant / registration holder
- COVIDIEN PRIVATE LIMITED
The intended purpose of the device is to create and maintain a port of entry into a body cavity. The trocar may be used with or without visualization for primary and secondary insertions. The VersaOne™ Optical Trocars with Fixation Balloon Cannula are indicated for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures. The trocar may be used with or without visualization for primary and secondary insertions.
- 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.