Deaver x = 22 mm RETRACTORS – Wound Retractors (Ref RT 11-540-02)

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Premium quality Deaver x = 22 mm RETRACTORS – Wound Retractors manufactured from 316L stainless steel by Fizza Surgical, Sialkot, Pakistan. ISO 13485:2016 certified. CE marked under EU MDR 2017/745. DHL Express worldwide shipping.

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 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 RT 11-540-02 Category
Regulatory Nomenclature
EMDN (EUDAMED): V020303
GMDN Code: 47587
Surgical retractor, reusable

Fizza Surgical supplies the Deaver x = 22 mm RETRACTORS – Wound Retractors (Ref RT 11-540-02) as a standard catalogue line to hospitals and distributors.

Self-retaining retractor frames removed one of the most fatiguing roles in open surgery — the assistant who held wound edges apart for hours of pelvic, abdominal, or thoracic work. The Balfour frame opens abdominal incisions with lateral blades and an optional bladder blade. The Bookwalter system anchors to the operating table with a horseshoe ring and accepts multiple interchangeable blades positioned around the wound edge. The Weitlaner and Gelpi serve superficial and orthopaedic exposures with sharp or blunt prongs locked by a ratchet on the cross-bar. Material requirements are demanding: the frame must resist deformation under sustained retraction load, which is why most self-retaining systems use AISI 440 or 17-4 PH precipitation-hardened stainless steel, while hand-held variants typically use AISI 304 austenitic stainless for corrosion resistance through repeated autoclave cycles. Fizza manufactures the full self-retaining range under ISO 13485:2016.

Reference / SKURT 11-540-02
PatternDeaver
Working length22 mm (2.2 cm)
MaterialAISI 304 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
Other Deaver sizes in our catalogue:

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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