Cusco Side Screw Medium 85mm x 35mm Vaginal Speculum

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Cusco Side Screw

its Available in all sizes Small Medium Large. we can manufacturer and design your vaginal speculums with your drawing in best quality with competitive price. Also you can give us the reference of any international brand of which you need.

MOQ: 50 pieces
Lead time: 18–22 working days
Sample order: 10 units · sample fee credited against first PO
OEM private label: Private-label from 300 units per SKU
Materials: AISI 304 / AISI 316 austenitic surgical-grade stainless steel
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU GY 12-100-02 Category
Regulatory Nomenclature
EMDN (EUDAMED): V02040101
GMDN Code: 39814
Vaginal speculum, reusable

Catalogue reference GY 12-100-02 — Cusco Side Screw Medium 85mm x 35mm Vaginal Speculum, supplied to hospitals, distributors, and OEM partners.

The Cusco vaginal speculum is named for Édouard-Gabriel Cusco, a nineteenth-century French gynecologist who refined the bivalve speculum design now standard in gynecological examination and minor procedures. The Cusco is single-handed and self-retaining via a ratchet that holds the valves open at the angle set by the examiner. Sizes are typically described as small (virgin), medium, and large, with corresponding blade lengths around 75 mm, 95 mm, and 115 mm. Modern Cusco specula are available in both reusable stainless steel and sterile single-use plastic; the reusable steel version with polished finish remains standard in office gynecology where good visualization is essential.

Reference / SKU GY 12-100-02
Pattern Cusco
Working length 85 mm (8.5 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 (EU MDR 2017/745) · FDA-registered
Other Cusco sizes in our catalogue:

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.

What is the minimum order quantity for Fizza Surgical instruments?
Standard MOQ is 300 units per SKU for catalogue items, 500 units for fully custom designs. Sample orders of 10 units per SKU are available with the sample fee credited against the first production order.
Are Fizza Surgical instruments CE-marked and ISO 13485 certified?
Yes. All instruments are manufactured under an ISO 13485:2016 Quality Management System, CE-marked under EU MDR 2017/745, and our facility is FDA-registered. Specific certificate numbers and PDFs are on our Certifications page.
How long is the lead time and what shipping options are available?
18–22 working days for catalogue items, 28–35 days for custom designs. Shipping via DHL Express, UPS, FedEx, or sea freight on all standard Incoterms (EXW, FCA, FOB, CIF, DAP).
Can I order a custom OEM private-label run with my own branding?
Yes — private-label manufacturing from 300 units per SKU. Co-branded packaging, custom instrument-set design, and laser etching with your brand are all available.

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