Stratte Needle Holder 230mm (23cm)

Stratte Needle Holder 230mm (23cm) · SKU NH 10-185-01 — manufactured to ISO 13485:2016.

Wound closure is the final and arguably the most visible phase of any open surgical procedure — and the needle holder is the surgeon’s mechanical link to every stitch. The jaw surface defines the performance envelope: fine cross-hatched grooves resist needle rotation under torque, the box-lock joint must have zero side-play, and the ratchet must engage cleanly without forcing the surgeon to fight the instrument. Tungsten-carbide jaw inserts — marked by gold ring-handles in the standard convention — extend service life by a factor of ten over plain stainless and resist the jaw-surface wear that ends conventional needle holders within hundreds of autoclave cycles. Length selection matches anatomy: 13-15 cm for paediatric and dental work, 18 cm for general surgery, 22-26 cm for deep pelvic and cardiac approaches. Fizza manufactures the full range under ISO 13485:2016.

Manufacturing compliance is verified through ISO 13485:2016 certification (the international medical-device quality standard), CE marking under EU MDR 2017/745, and FDA establishment registration. Certificate copies and regulatory documentation are available on request for inclusion in hospital procurement files and EU technical documentation packages. Sterilization validation follows ISO 17665 for steam autoclave at 134 °C.