| Material |
Primary Material |
316L Stainless Steel (UNS S31603), Vacuum Melted (316LVM) optional for highest purity. |
| |
Certification |
ASTM A269, ISO 13485 compliant material traceability. Biocompatible per ISO 10993-1. |
| Base Tubing |
Outer Diameter (OD) |
1.5 mm to 6.0 mm (Common range: 2mm, 3mm, 4mm). Corresponds to cannula gauge (e.g., 3mm ≈ 10G). |
| |
Inner Diameter (ID) |
Slightly smaller than OD, defining aspiration lumen size. Tight tolerance control. |
| |
Wall Thickness |
0.3 mm to 0.8 mm (Balance of strength and internal flow area). |
| |
Length |
150 mm to 400 mm (Standard surgical lengths). |
| Tip & Port Design (CNC Milled) |
Tip Types |
Multi-Port (e.g., Mercedes), Single Port, Spatula, Cobra, Basket. Custom geometries. |
| |
Aspiration Ports |
Number (1 to 4+), size (diameter/length: 1x3mm oval, etc.), and precise radial/longitudinal position. |
| |
Port Edge Finish |
Electropolished to a smooth, atraumatic edge to minimize tissue damage. |
| |
Tip Geometry Tolerance |
Critical features held to ±0.05 mm. |
| Proximal Connection |
Connection Type |
Machined Threads (e.g., for Luer-lock hub), Barbed End, or custom OEM interface. |
| |
Concentricity |
High concentricity between aspiration lumen and connection (< 0.05 mm TIR). |
| Surface & Performance |
Internal Lumen Finish |
Mirror Electropolish. Ra ≤ 0.2 µm. Essential for smooth fat passage and cleanability. |
| |
External Surface Finish |
Full-body electropolish, Ra ≤ 0.2 µm. |
| |
Flow Characteristics |
Optimized by port design and internal finish to balance aspiration efficiency and tissue preservation. |
| |
Pressure Rating |
Withstands typical surgical suction pressures (up to 1 atm of vacuum). |
| Quality & Compliance |
Dimensional Inspection |
100% critical dimension check via video measurement system or CMM. |
| |
Metrology Report |
Dimensional report for tip geometry, port location/size, and ID/OD. |
| |
Cleanliness & Bioburden |
Cleaned to meet or exceed ISO 11737-1 bioburden standards for sterile devices. |
| |
Sterilization Compatibility |
Designed for terminal sterilization (Gamma, ETO, Steam). Supplied non-sterile (component) or sterile. |
| |
Regulatory Support |
Manufactured under ISO 13485. Design History File (DHF) support available for device OEMs. |