Franklin-Silverman Liver Biopsy Needle 105mm — Pre-Menghini Standard

$ 0

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 DI 01-720-01 Category
Regulatory Nomenclature
EMDN (EUDAMED): V02
GMDN Code: 47555
Surgical instrument, reusable

Franklin-Silverman 105mm Liver Biopsy Needle — Pre-Menghini Standard

The standard Franklin-Silverman 105mm liver-biopsy needle is the unmodified Vim-Silverman 1938 design that defined percutaneous liver biopsy in the pre-Menghini era. The procedure required 30-60 seconds of pleural-cavity transit during the cutting-biopsy action — the duration that produced the 5-10% pneumothorax complication rate that Menghini’s one-second technique reduced to under 1% in 1957.

The historical clinical context

Percutaneous liver biopsy was first reported by Lucatello in 1895 but did not become a routine procedure until the Vim-Silverman 1938 description provided a reproducible technique. The procedure transformed hepatology by enabling tissue diagnosis of chronic liver disease without surgical exploration. The complication rate of 5-10% (mostly pneumothorax and pleural-cavity bleeding) was acceptable in the pre-antibiotic era when the diagnostic alternative was surgical biopsy with substantially higher mortality.

The modern indication-spectrum

The 105mm Franklin-Silverman remains in use at centres where Menghini technique is unavailable, where cutting-biopsy architecture is specifically indicated, or where operator training favours the cutting-needle approach. Most modern liver biopsy is Menghini-technique or core-cutting-needle (e.g., 18G Achieve, Tru-Cut), but the Franklin-Silverman pattern persists in specific clinical-pathological indications.

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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