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| Customization: | Available |
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| After-sales Service: | 3 Months |
| Warranty: | 3 Months |
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Material | Cutting Cannula | High-hardness stainless steel (e.g., 420J2, 17-4PH hardened to ~45 HRC). Optional Tungsten Carbide tips. |
Handle/Hub | Medical-grade polymers (Polycarbonate, ABS) and/or anodized aluminum. | |
Rotary Bearing | Medical-grade stainless steel or ceramic micro-bearing. | |
Needle Specifications | Gauge (Outer Diameter) | Common: 14G, 16G, 18G (2.1 mm, 1.6 mm, 1.3 mm). Range: 11G to 20G. |
Cutting Length | 10 mm to 25 mm (standard for biopsy). Custom lengths available. | |
Needle Overall Length | 100 mm to 250 mm (procedure-specific). | |
Tip/Cut Design | Side-notch (Tru-Cut type),End-cutting,Serrated edge,orFull-core (Temno type). | |
Inner Stylet | Optional co-axial obturator/stylet for tissue retention. | |
Rotational Mechanism | Actuation Type | Manual (Thumb-wheel/Gear),Battery-Powered (Disposable Motor),orConnects to Reusable Powered Driver. |
Rotation Control | Uni-directional (standard) or oscillating. | |
Rotation Speed (Powered) | Variable, typically 200 – 1500 RPM (for motorized versions). | |
Torque Output | Sufficient to cut through designated tissue types without stalling. | |
Ergonomics & Features | Handle Design | Ergonomic, ambidextrous grip with textured surface. |
Aspiration Port | Integrated Luer lock port for syringe connection to apply vacuum. | |
Depth Gauge/Stop | Adjustable slide or fixed stop to control insertion depth. | |
Activation | Push-button, slide, or trigger on the handle. | |
Performance | Tissue Core Quality | Designed to yield intact, non-fragmented cores of specified length and diameter. |
Penetration Force | Reduced compared to non-rotating needles. Validated per test method. | |
Deflection | Minimal deviation during insertion into heterogeneous tissue. | |
Sterility & Single-Use | Sterilization Method | Validated Gamma Irradiation or Ethylene Oxide (EO). |
Sterility Assurance Level (SAL) | 10 | |
Packaging | Sterile barrier system (Tyvek®/plastic pouch) within protective clamshell. Labeled "Single Use Only". | |
Quality & Compliance | Biocompatibility | Complies with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation). |
Functional Testing | 100% tested for rotation, cutting edge sharpness, and assembly integrity. | |
Sharpness/Cutting Test | Performance tested on validated tissue simulants. | |
Regulatory | Designed and manufactured per ISO 13485, supports FDA 510(k)/CE Mark submissions. | |
Labeling | Includes gauge, length, lot number, expiry date, sterilization method. | |








