HSA · registration DE0505212Covidien Valleylab™ Smoke Evacuation Rocker Switch Pencils
- Registration number
- DE0505212
- Model name
- ValleylabTM Smoke Evacuation Extension Tube; ValleylabTM Smoke Evacuation Extension Tube; ValleylabTM Smoke Evacuation Rocker Switch Pencil; ValleylabTM Smoke Evacuation Rocker Switch Pencil; ValleylabTM Smoke Evacuation Rocker Switch Pencil; ValleylabTM Smoke Evacuation Rocker Switch Pencil; ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil; ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil; ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil; ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil
- Model identifier
- SEA50595; SEA54506; SEP5000; SEP5000NSB; SEP5015; SEP5015NSB; SEP6000; SEP6000NSB; SEP6015; SEP6015NSB
- Registration date
- December 07, 2020
- Source update date
- October 12, 2022
- Risk class
- Class B
- Product owner
- Covidien llc
- Registrant / registration holder
- COVIDIEN PRIVATE LIMITED
The smoke evacuation rocker switch pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
- 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.