Device Dossier
Gastrointestinal Anchor Set with Saf-T-Pexy T-Fasteners - Surgical procedure kit, general-purpose, single-use, non-medicated
Device Dossier for Gastrointestinal Anchor Set with Saf-T-Pexy T-Fasteners - Surgical procedure kit, general-purpose, single-use, non-medicated (Surgical…
Intended purpose
The Gastrointestinal Anchor Set with SAF-T-PEXY T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the MIC* and MICKEY* Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the MIC and MIC-KEY Enteral Feeding Tubes.
Functional description
The Saf-T-Pexy with T-Fasteners provides confidence in securing the stomach to the abdominal wall. It includes 4 pre-loaded T-Fasteners with absorbable 3/0 Biosyn suture. It eliminates the need for suture removal. There is audible confirmation of suture lock with comfortable external retention. The focus is on safety i.e. single-use, pre-loaded safety needles preventing unintentional sticks.