Device Dossier
PARASORB Fleece HD - Collagen haemostatic agent
Device Dossier for PARASORB Fleece HD - Collagen haemostatic agent (Collagen haemostatic agent, Class III, sponsor Ozdent). ARTG record, intended…
- GMDN category: Collagen haemostatic agent
Intended purpose
PARASORB Fleece HD is used as a haemostatic agent after tooth extraction and oral surgery. PARASORB Fleece HD can be combined with fibrin glue in patients with increased risk of bleeding.
Functional description
1 PARASORB Fleece HD 1.8cmx3.6cm contains 36.2mg, & 3cmx7cm contains 117.6mg of native collagen fibrils of equine origin. The application of PARASORB Fleece HD into the defect cavity supports stabilization of the produced blood clot whilst helping to control bleeding at the application site. Should be used in dry state with light pressure, inserted into the extraction socket or cavity as required. Can be sutured over and/or held in place with fibrin glue as required. Absorbed within 3-4 months.