Device Dossier
Oxiplex/AP Gel - Barrier, absorbable, adhesion prevention
Device Dossier for Oxiplex/AP Gel - Barrier, absorbable, adhesion prevention (Barrier, absorbable, adhesion prevention, Class III, sponsor Fziomed). ARTG…
- GMDN category: Barrier, absorbable, adhesion prevention
Intended purpose
Oxiplex/AP is intended for use as a mechanical barrier to adhesion formation. It is intended to be used as an adjunct to intrauterine or peritoneal surgery for reducing the incidence, extent, and severity of postoperative adhesions at the surgical site.
Functional description
Oxiplex/AP is a clear, single use flowable gel. The gel is a sterile, absorbable combination of polyethylene oxide (PEO) and sodium carboxymethylcellulose (CMC). The gel is calcium stabilized, isotonic, and has been shown in preclinical studies to clear the peritoneal cavity within 30 days. It is supplied sterile in a thermoform tray which contains two 20mL syringes of gel and one gel applicator.