Description

The Camden Surgical Vascular Pack is expertly designed to meet the stringent demands of operative procedures, offering a comprehensive single-use solution for healthcare professionals. As a Single-Use Operative Procedure Pack (SOPP), it provides essential components in a sterile environment, ensuring readiness and reliability in surgical settings.

Key Features

• Regulatory Compliance: Adheres to Australian SOPP regulations, encompassing labelling, documentation, and post-market monitoring requirements. This compliance assures healthcare providers of its quality and safety standards.

• Contents Identification: Each pack is equipped with detailed information to identify its contents, along with Instructions for Use (IFU) for each item, as provided by the original manufacturer. This transparency enhances usability and trust.

• IFU Management: Should any IFU be modified by Camden, the responsibility for conformity assessment is assumed, maintaining the integrity and reliability of the pack's components.

Implantable Device Information

For packs containing implantable medical devices, the provision of patient information materials, such as implant cards and information leaflets, is included, except for specific exclusions like sutures and staples. This ensures comprehensive patient communication and record-keeping.

Electronic Instructions for Use

Electronic IFUs are available for professional users, streamlining access to essential information while maintaining compliance with regulatory standards. However, these are not intended for public supply, aligning with privacy and accessibility guidelines.

Professional Application

The Camden Surgical Vascular Pack is tailored for professional healthcare environments, offering a reliable, compliant, and well-documented solution for surgical procedures. Its meticulous design and adherence to regulatory frameworks make it an invaluable asset in medical settings, supporting surgical teams with precision and care.