Modified USA Narrow 12cm — SILS Cholecystectomy

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Modified USA 12cm Narrow Dressing Forceps

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 420 / AISI 440 / 17-4 PH stainless steel · tungsten-carbide inserts where applicable
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU DF 03-35-01-01 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V02010301
GMDN Code: 47571
Dressing forceps/tweezers, reusable

Modified USA Narrow 12cm — SILS Cholecystectomy

The 12cm-labelled Modified USA Narrow dressing forceps serves single-incision laparoscopic cholecystectomy (SILS-cholecystectomy) — the operation that performs gallbladder removal through a single 2-3cm umbilical incision rather than the four ports of standard laparoscopic technique. The narrow profile suits the cramped working space of single-port instrumentation, and the 12cm length fits the SILS-instrument tray ergonomics.

The SILS-cholecystectomy evolution

Single-incision laparoscopic cholecystectomy emerged in the late 2000s as an alternative to standard four-port laparoscopic technique, motivated by the cosmetic advantage of a hidden umbilical scar. Outcomes are equivalent to standard laparoscopic cholecystectomy in selected patients; operating time is slightly longer and the technique requires specialised single-port-platform devices. The 12cm Modified USA Narrow lives in the SILS-conversion tray for cases that need open completion.

The patient-selection criteria

SILS-cholecystectomy is offered to selected patients — typically BMI <35, no previous upper abdominal surgery, no acute cholecystitis. Patients outside these criteria undergo standard laparoscopic technique. The 12cm Narrow forceps's specific role is within the appropriate-patient subset.

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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