Vitrectomy system micro-cutting unit
Access comprehensive regulatory information for Vitrectomy system micro-cutting unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Insight Surgical, manufactured by Aktive S.R.L. in Italy. The device registration started on October 01, 2019.
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A sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove vitreous humour during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and is used with the irrigation/suction systems (separately provided) needed to supply replacement fluid and remove debris. This is a single-use device.