The Kristeller Set 110mm x 36mm + 115mm x 32mm Vaginal specula (Ref GY 12-250-07) is part of the Fizza Surgical instrument catalogue, manufactured under ISO 13485:2016.
| Reference / SKU | GY 12-250-07 |
| Working length | 110 mm (11 cm) |
| Material | AISI 304 / AISI 316 austenitic surgical-grade stainless steel |
| Sterilization | Steam autoclave to 134 °C · EtO compatible |
| Quality system | ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered |
- Kristeller Set 110mm x 30mm + 115mm x 26mm Vaginal specula (GY 12-250-06)
- Kristeller Upper Blade 115mm x 23mm — Extra-Deep Narrow (GY 12-245-05)
- Kristeller Set 110mm x 27mm + 70mm x 15mm Vaginal specula (GY 12-250-05)
Specialty surgical instruments cover the patterns developed for specific anatomical regions or procedures: ophthalmic micro-instruments, cardiac vascular clamps, neurosurgical micro-dissectors, plastic-surgery skin handling tools, ENT precision instruments, and paediatric variants of standard patterns. The defining characteristic across the category is dimensional precision: tolerances are tighter, working tips are finer, and the metallurgy is often optimized for specific tasks — titanium for microsurgery where weight matters, tungsten-carbide for sustained sharpness in vascular work, and high-polish finishes for ophthalmic instruments used under microscope. Fizza manufactures specialty patterns under ISO 13485:2016 with material and finish options configurable per OEM specification.
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.





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