Simon Fistula Hook (GY 12-485-01)

Simon Fistula Hook

Simon Fistula Hook, 2 catalogue references (GY 12-485-01 to GY 12-485-02).

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 12-485 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V02040114
GMDN Code: 47591
Fistula hook

Fizza Surgical lists the Simon Fistula Hook under 2 catalogue references, GY 12-485-01 to GY 12-485-02. Fistula hooks are used in the repair of vaginal fistulas.

Catalogue references

ReferenceDescription
GY 12-485-01Simon 220mm (22cm) Fistula hooks
GY 12-485-02Simon 220mm (22cm) Fistula hooks

Quote the reference you need when you send an inquiry.

Specification

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

See the rest of the range under Fistula Hooks.

Made at the Fizza Surgical International facility in Sialkot, in operation since 1980, under ISO 13485:2016 with CE marking under EU MDR 2017/745 and FDA establishment registration.

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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