Device Dossier

SURGICEL Powder Absorbable Haemostatic Powder - Surgical plant polysaccharide haemostatic agent

Device Dossier for SURGICEL Powder Absorbable Haemostatic Powder - Surgical plant polysaccharide haemostatic agent (Surgical plant polysaccharide…

Intended purpose

SURGICEL® Powder (oxidised regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial haemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL Powder can also be applied in laparoscopic or other endoscopic procedures when used with the SURGICEL Endoscopic Applicator.

Functional description

SURGICEL® Powder contains Oxidised Regenerated Cellulose (ORC) prefilled in an applicator to dispense on a target bleeding site. SURGICEL® Powder is white with a pale yellow cast and has a faint, caramel-like aroma. It is stable and should be stored at controlled room temperature. A slight discoloration may occur with age, but this does not affect performance. SURGICEL® is bactericidal due to low pH characteristics against a wide range of pathogenic microorganisms.

TGA Public Summary