Material Composition | Surgical Procedures Requiring Corrosion Resistance | Stainless Steel (ASTM A240/A240M compliant) ▲ (vs Industry Standard ASTM A240) | Enhanced corrosion resistance and durability (withstands repeated sterilization) | Slightly higher cost than non-compliant materials |
Safety Compliance | Regulatory-Compliant Medical Settings | MFDS (Korea) Certified ▲ (vs ISO 13485 for Base Model) | Meets strict Korean medical standards (validated for biocompatibility) | Limited to regions recognizing MFDS certification |
Shelf Life | Long-Term Storage in Medical Facilities | 5 years (Advanced) ▲ (vs Industry 3 years) | Extended usability reduces replacement frequency (verified via ISO 11137) | Requires proper storage to maintain sterility and integrity |
Instrument Type/Class | Class I Medical Device Applications | Class I (Low Risk) ▲ (vs Higher Class Devices) | Streamlined regulatory compliance (simplified procurement for routine use) | Perceived as less specialized for complex procedures requiring precision |
Warranty Period | Customer Confidence in Durability | 5-year warranty ▲ (vs Industry Standard 2 years) | Enhanced customer assurance (covers manufacturing defects under normal use) | Potentially higher initial cost compared to non-warranty competitors |
Diameter/Weight Range | Versatile Urethral Dilation Procedures | 6–12mm diameters (23.4g–30.39g) ▲ (vs Single-Size Competitors) | Customizable for varying patient needs (ISO 3801-certified uniformity) | Requires proper sizing selection training to avoid mismatched applications |
Length Consistency | Standardized Storage and Handling | Uniform 227mm length ▲ (vs Variable Lengths) | Streamlined inventory management (stackable design for compact storage) | Limited flexibility for non-standard procedural requirements |