Bag, Tissue Extraction

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Getz Healthcare Pty Ltd

Class:

Class IIa

Manufactured by:

Synergy Health UK Ltd 1 Western Avenue Matrix Park Buckshaw Village, Chorley, Lancashire, PR77NB United Kingdom

Therapeutic area:

45130 - Bag, tissue extraction

Therapeutic indications:

An impervious, flexible, container used during minimal invasive surgery for the extraction of dissected patient body tissue typically involving keyhole surgery techniques, e.g., laparoscopic surgery. The device is inserted into the body through a large bore cannula port and the tissue to be extracted is placed in the bag with instruments and drawn up through the cannula. It is made of a strong, flexible, material, typically including an x-ray detectable thread. This device can be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, and gall bladder removal. This is a sterile, single-use device.

Authorization status:

A

Authorization date:

2011-11-07