Device Dossier
Guardix-SG - Barrier, absorbable, adhesion prevention
Device Dossier for Guardix-SG - Barrier, absorbable, adhesion prevention (Barrier, absorbable, adhesion prevention, Class III, sponsor Juniper…
- GMDN category: Barrier, absorbable, adhesion prevention
- Sponsor: Juniper Biologics
Intended purpose
Guardix-SG anti-adhesion barrier is intended to prevent or reduce the post-surgical adhesion formation around the surgery region.
Functional description
Guardix-SG is a sterile, absorbable, non-pyrogenic, transparent viscous poloxamer/sodium alginate gel. It is a temperature-sensitive anti-adhesive agent that is maintained in the flowable sol-state before application, yet transformed to the gel-state when being applied to the wound area after surgery to form adhesion. Biologically safe and excreted mostly within 28 days, Guardix-SG is supplied sterile in a pre-filled syringe for single use only.