Universal Trocars Aspiration

$ 0

Universal Trocars Aspiration

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 DI 01-595-00 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V02
GMDN Code: 47555
Surgical instrument

The Universal Trocars Aspiration (SKU DI 01-595-00) is part of the Fizza Surgical catalogue.

From a procurement standpoint, surgical forceps are the most volume-intensive line in any operating-room instrument inventory: a standard general-surgery tray carries six to twelve forceps, and a large hospital cycles thousands through central sterile services every week. The metallurgy matters at that scale. AISI 420 stainless covers the majority of soft-tissue patterns where corrosion resistance and edge retention are the priority; AISI 440 and 17-4 PH are used on the heavier patterns where the jaws transmit higher closing force. Tungsten-carbide tip inserts roughly ten times the service life of plain stainless tips on toothed and serrated jaws. Fizza manufactures the full forceps catalogue at the Sialkot facility under ISO 13485:2016 with OEM private-label programs available from 300 units per SKU.

Reference / SKUDI 01-595-00
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
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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 (MOQ) for OEM private-label surgical instruments?
The MOQ is 300 units per SKU for catalogue items and 500 units per SKU for fully custom designs. Mixed-SKU orders aggregating 1,000+ units across a single product family qualify for the private-label tier. Sample orders of 10 units per SKU are available; the sample fee is credited against the first production order.
Are Fizza Surgical instruments CE-marked and FDA-registered?
Yes. All instruments are manufactured under an ISO 13485:2016 Quality Management System, CE-marked under EU MDR 2017/745, and our manufacturing facility is registered with the U.S. FDA as a Foreign Establishment for Class I exempt surgical instruments. Specific certificate numbers and downloadable PDFs are available on our Certifications page.
What stainless steel grades are used?
Medical-grade AISI 420 for general surgical instruments, AISI 440 or 17-4 PH for high-stress applications, and tungsten-carbide inserts on needle holders and high-precision scissors. Mill test certificates are available on request with every order.
How long is the lead time and what shipping methods are available?
18–22 working days for catalogue items, 28–35 days for fully custom designs. Shipping options include DHL Express (4–5 business days to most EU and US destinations), UPS, FedEx, and sea freight on all standard Incoterms (EXW, FCA, FOB, CIF, DAP).
Can I visit the Sialkot factory for an audit?
Yes. Distributor and audit visits are welcome and we arrange transport from Sialkot or Lahore airport. Email our quality team to schedule.

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