Mathieu 195mm – 7 3/4 ” specula

Mathieu 195mm – 7 3/4 ” specula

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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Category
Regulatory Nomenclature
EMDN (EUDAMED): V020703
GMDN Code: 47632
Rectal speculum

Fizza Surgical supplies the Mathieu 195mm – 7 3/4 '' specula as a standard catalogue line to hospitals and distributors.

Mathieu needle holders are distinguished from the standard Mayo-Hegar by their squeeze-action handle design — the ratchet locks when the handles are squeezed together fully, and releases on a further squeeze. This single-handed operation appeals to surgeons working in confined spaces (oral surgery, deep cavity work) where the standard finger-ring Mayo-Hegar is cumbersome. The pattern is named for nineteenth-century French dental surgeon Paul Mathieu who developed it for intraoral suture work. Standard length is 14 cm. Tungsten carbide insert variants extend the working life of the jaw cross-hatching across thousands of autoclave cycles.

PatternMathieu
Working length195 mm (19.5 cm)
MaterialAISI 304 / AISI 316 austenitic surgical-grade stainless steel
SterilizationSteam autoclave to 134 °C · EtO compatible
Quality systemISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

Every instrument is forged, machined, and finished at the Sialkot facility from German-origin stainless billet — austenitic 304 / 316 grades for non-cutting, mucosal-contact, and hollow-ware lines where corrosion resistance is the priority, martensitic 420 / 440 grades for cutting and edge-retention patterns where heat-treatable hardness matters, and 17-4 PH precipitation-hardened stainless for high-load orthopedic and implant-handling applications. Polishing, passivation, and final inspection are performed in-house under documented quality procedures aligned with ISO 13485:2016.

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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