Device Dossier
Oxiplex Gel - Barrier, absorbable, adhesion prevention
Device Dossier for Oxiplex Gel - Barrier, absorbable, adhesion prevention (Barrier, absorbable, adhesion prevention, Class III, sponsor Fziomed). ARTG…
- GMDN category: Barrier, absorbable, adhesion prevention
Intended purpose
Oxiplex is intended for use a mechanical barrier to adhesion formation. It is intended to be placed around the neural tissues following spine surgery to reduce adhesion formation and related symptoms such as pain.
Functional description
Oxiplex is a flowable gel. It is a sterile, absorbable, isotonic, combination of polyethylene oxide (PEO) and sodium carboxymethylcellulose (CMC) with calcium chloride in sterile water for injection. It is non-pyrogenic.