Device Dossier
Seprafilm - Barrier, absorbable, adhesion prevention
Device Dossier for Seprafilm - Barrier, absorbable, adhesion prevention (Barrier, absorbable, adhesion prevention, Class III, sponsor Baxter Healthcare).…
- GMDN category: Barrier, absorbable, adhesion prevention
- Sponsor: Baxter Healthcare
Intended purpose
Seprafilm is intended as an adjunct in abdominal and pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement, and to reduce adhesive small bowel obstruction when placed in the abdomen.
Functional description
Seprafilm is sterile, bioresorbable translucent membrane that is resorbed within one week and excreted from the body in less than 30 days. Therefore, no procedure is required to remove the membrane and there is no risk of reuse. Seprafilm is applied to sites of potentially adhesiogenic tissue and organ structures in the abdominopelvic cavity to serve as a temporary barrier separating opposing tissue surfaces. Seprafilm is for single use only and must not be resterilised.