Device Dossier

Hemogelatin - Gelatin haemostatic agent

Device Dossier for Hemogelatin - Gelatin haemostatic agent (Gelatin haemostatic agent, Class III, sponsor Specialites Septodont). ARTG record, intended…

Intended purpose

Hemogelatin can be used dry or soaked with sterile saline solution, for surgical interventions, except for ophthalmic ones, through simple application or by exerting slight pressure like a haemostatic device for controlling the bleeding of venous or arteriolar capillaries, and in cases where other conventional haemostatic procedures (stitching, compression, binding etc) cannot be carried out. Hemogelatin can be cut to the desired size without crumbling, using sterile scissors, and it has low adhesiveness with respect to forceps and surgery instruments.

Functional description

Hemogelatin is a sterile gelatin sponge from animal origin, insoluble in water, easy to handle and re-absorbable. Its purpose is to facilitate the stopping of bleeding. The sponge is whitish with uniform porosity. Once saturated with blood, the product promotes coagulation by serving as a coadjutant for controlling local haemorrhage. If utilised correctly and in suitable amounts, Hemogelatin is reabsorbed within 3-4 weeks.

TGA Public Summary