Applied Medical Alexis Contained Extraction System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

APPLIED MEDICAL SINGAPORE PTE. LTD.

Class:

Class B medical device

Manufactured by:

Applied Medical Resources Corporation

Therapeutic area:

General Hospital

Therapeutic indications:

The Alexis contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach. Kii balloon blunt tip systems and the GelPOINT Mini advanced access platform are indicated for use in general, abdominal, gynaecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extra peritoneal and/or potential spaces for endoscopic instruments. The GelPOINT advanced access platform is intended for use in obtaining abdominal access by instrumentation in patients undergoing laparoscopic surgical procedures. Sleeves may be placed through the GelSeal® cap to allow instrument access to the surgical site. The device may be used in procedures such as nephrectomy, colectomy and splenectomy in urological, colorectal and general surgery to access the surgical site.

Product summary:

Device System Info:[Sterile Medical Device], Alexis CES - EO Kii Balloon - E-Beam irradiation GelPoint / GelPoint Mini - Gamma irradiation and Ethylene Oxide (EO) sterilisation; Models: Alexis contained extraction system, ring diameter 14cm, bag volume 3400mL - GTB14, Alexis contained extraction system, ring diameter 17cm, bag volume 6500mL - GTB17, Alexis Contained Extraction System with GelPOINT Advanced Access Platform - GTG14, Alexis Contained Extraction System with GelPOINT Advanced Access Platform - GTG17, Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform - GTM14, Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform - GTM17, Alexis Contained Extraction System with Kii Balloon Blunt Tip System - GTK14, Alexis Contained Extraction System with Kii Balloon Blunt Tip System - GTK17

Authorization date:

2018-11-28