Device Dossier
ENTACT Septal Stapler - Intranasal splint, biodegradable
Device Dossier for ENTACT Septal Stapler - Intranasal splint, biodegradable (Intranasal splint, biodegradable, Class III, sponsor Smith & Nephew). ARTG…
- GMDN category: Intranasal splint, biodegradable
- Sponsor: Smith & Nephew
Intended purpose
The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
Functional description
The ENTACT Septal Stapler consists of resorbable fixation devices, which are delivered via a manual surgical stapler delivery system. Each sterile, single patient use device contains eight ENTACT staples for holding the septal tissues together during post-op healing. The ENTACT staple is designed to resorb in about 3 to 6 weeks when used according to labeling.