Device Dossier
HyaRegen Gel - Wound hydrogel dressing, sterile
Device Dossier for HyaRegen Gel - Wound hydrogel dressing, sterile (Wound hydrogel dressing, non-antimicrobial, Class III, sponsor Endotherapeutics).…
- GMDN category: Wound hydrogel dressing, non-antimicrobial
- Sponsor: Endotherapeutics
Intended purpose
HyaRegen Gel is indicated for the prevention or reduction of post-surgical adhesion formation in the abdomino-pelvicarea after laparoscopic/hysteroscopic and open gynaecological surgical procedures.
Functional description
Highly viscous absorbable anti-adhesion barrier gel. The gel is applied to the surgical site where it adheres to the tissue surface and creates an anti-adhesion barrier, keeping adjacent tissues separated following surgery. The gel is intended to be absorbed within 30 days of application.