Collin Bone Mallet

$ 0

COLLIN – Bone Mallets, Bone Surgery

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 440 / 17-4 PH precipitation-hardened 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 BS 14-45-00 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V02050106
GMDN Code: 35266
Bone mallet

Catalogue reference BS 14-45-00 — Collin Bone Mallet, supplied to hospitals, distributors, and OEM partners.

Collin retractors are a family of self-retaining frame retractors used across abdominal, pelvic, and orthopaedic surgery. The Collin pattern shares a heavy frame design with adjustable lateral blades that maintain wound exposure without requiring an assistant to hold the retractor. The Collin abdominal retractor is the most common variant — used during laparotomy for deep cavity exposure when the larger Balfour or Bookwalter frames are not needed. Lengths and blade depths vary by application. Modern Collin instruments are made from medical-grade stainless steel for autoclave durability and corrosion resistance across decades of operating-theatre use.

Reference / SKUBS 14-45-00
PatternCollin
MaterialAISI 440 / 17-4 PH precipitation-hardened stainless steel
SterilizationSteam autoclave to 134 °C · EtO compatible
Quality systemISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

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.

Which orthopedic procedures are your bone-surgery instruments designed for?
General orthopedic surgery, ORIF (Open Reduction Internal Fixation), spinal surgery, joint replacement, trauma surgery, and veterinary orthopedic applications. Catalogue includes bone holding forceps, cutters, gouges, chisels, ronguers, periosteal elevators, and rasps.
What stainless steel grade is used for bone-surgery instruments?
AISI 440 or 17-4 PH (precipitation-hardened) stainless steel for high-stress instruments such as bone cutters, gouges, and chisels. Tungsten-carbide inserts on instrument tips where additional edge retention is required.
Are bone-surgery instruments compatible with steam autoclave sterilization?
Yes — all bone-surgery instruments are designed for repeat steam autoclave cycles at 134 °C and are also EtO compatible. Tungsten-carbide inserts are autoclave-safe.
What is the MOQ for orthopedic instrument private-label?
Standard MOQ is 300 units per SKU for catalogue items, or 50 sets for complete orthopedic kits. Custom designs require 500 units per SKU minimum.

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