Bag, tissue extraction
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2019
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Available from:
Sonita Medic Enterprises Pty Ltd
Class:
Class IIa
Manufactured by:
Hangzhou Optcla Medical Instrument Co Ltd No.2 Fengxiang Road Economic Development Zone Tonglu Hangzhou, Zhejiang , 311508 China
Therapeutic area:
45130 - Bag, tissue extraction
Therapeutic indications:
A sterile, endoscopy surgical instrument with attached pouch / bag intended to be used during minimal invasive surgery for the extraction of dissected patient body tissue typically involving keyhole surgery techniques, e.g., laparoscopic surgery. This device can be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, and gall bladder removal. This is a single-use device.
Authorization status:
A
Authorization date:
2018-01-18
