Objectives

The primary objective of this tender is to procure 50 units of Endoscopic Hydrotomes, specifically SPHINCTEROTOME ENDOSCOPIC HYDROTOME PRELOADED 4,4FR, for use by general surgeons during ERCP procedures on GI patients at Dr Pixley Ka Isaka Seme Memorial Hospital.

Scope

The scope encompasses the supply of endoscopic hydrotomes that meet detailed specifications, including single-use, sterile, preloaded 4.4FR shaft length of 200cm, with a catheter size of 5mm and 20mm cut wire, equipped with a double-sided floppy tip guidewire and direct tip technology. The procurement is a once-off purchase, with delivery to the specified hospital address, and includes compliance with quality standards and sample submission for evaluation.

Technical Requirements

• Single-use, sterile endoscopic hydrotome.
• Preloaded 4.4FR shaft with 200cm working length.
• Catheter with 5mm diameter and 20mm cut wire.
• 260cm double-sided floppy tip guidewire.
• Incorporation of direct tip technology.
• Compliance with specified size, material, and quality standards.
• Samples must be provided for evaluation prior to award.
• Items must conform to SABS or SANS approved standards.

Skills and Competency Requirements

• Bidder must demonstrate the ability to supply medical devices compliant with South African standards.
• Provision of proof of previous successful delivery of similar medical equipment.
• Ability to provide technical support and documentation as required.
• Compliance with administrative and legal requirements, including valid licensing and registration with the South African Health Products Regulatory Authority (SAPHRA).
• Capacity to meet delivery timelines and quality assurance standards.