Wagener Ear Hook — Mayo-Pattern Foreign-Body Hook

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Wagener – Ear loops – hooks – ENT

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 EH 15-20-00 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V02030405
GMDN Code: 47591
Ear loops/hooks

The hooked tip lifts tissue or sutures from below — a specialized geometry for retraction and suture manipulation. Catalogue reference EH 15-20-00.

Reference / SKU EH 15-20-00
Pattern Mayo
Shape Hook
Material AISI 304 / AISI 316 austenitic surgical-grade stainless steel
Sterilization Steam autoclave to 134 °C · EtO compatible
Quality system ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

The Mayo brothers — William James and Charles Horace — founded what became the Mayo Clinic in Rochester, Minnesota, and lent their family name to a remarkable number of surgical instruments. Mayo scissors, the most common of the family, are heavy curved or straight dissecting scissors with thick blades for cutting fascia, suture, and tough tissue. The 14 cm and 17 cm lengths are most used. Mayo’s design philosophy emphasized robustness over delicacy: these are workhorses meant to outlast decades of autoclave cycles in a busy operating theatre. Curved Mayo scissors handle blunt and sharp dissection through fascial planes; straight Mayos are preferred for cutting suture and prepared tissue.

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 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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