Mastel Surgical Receives FDA 510(k) Clearance for SteriBest Sterilization Tray System
核心洞察
Mastel Surgical (搜索)'s SteriBest Sterilization Tray System (搜索) has received FDA 510(k) clearance for a 4-minute, 270°F (132°C) pre-vacuum steam sterilization cycle.
The system is designed to organize, protect, store, and transport delicate ophthalmic and microsurgical instruments throughout the reprocessing workflow.
Key features include durable Ultem polymer construction, transparent lids, stackable design, and slotted lids and bases for efficient circulation and rapid drying.
Mastel Surgical (搜索), a Pacific Surgical (搜索) company, announced that the SteriBest Sterilization Tray System (搜索) has received FDA 510(k) clearance for use with a 4-minute, 270°F (132°C) pre-vacuum steam sterilization cycle. The announcement, made from Schiller Park, Illinois, marks a significant regulatory milestone for the company and for healthcare professionals who depend on efficient, validated reprocessing workflows.
The SteriBest system is purpose-built to organize, protect, store, and transport delicate instruments throughout the reprocessing workflow, providing healthcare facilities with a practical tray solution for high-value instruments requiring careful handling. Manufactured in the USA, the system is available in multiple sizes and configurations, including options with pin mats, silicone bars, and specialty holders for ophthalmic and micro-instruments.
"This FDA 510(k) clearance marks an important milestone for SteriBest and for healthcare professionals who rely on efficient, validated reprocessing workflows," said Steve Sharpless, President of Mastel Surgical (搜索). "SteriBest was developed to help protect and organize delicate instruments while supporting facilities in standardizing their sterilization processes with added confidence."
Design and Technical Specifications
The SteriBest Sterilization Tray System (搜索) incorporates several design features aimed at enhancing usability and instrument protection. The trays are constructed from durable Ultem polymer, a high-performance thermoplastic known for its strength and chemical resistance. Transparent lids allow for easy identification of tray contents without opening, while a stackable design facilitates efficient storage in sterile processing environments. Slotted lids and bases are engineered to promote circulation of steam and facilitate rapid drying following the sterilization cycle.
The system is designed for use in surgery and sterile processing environments seeking a reliable tray solution for microsurgical and ophthalmic instruments, as well as other delicate medical devices.
OEM and Private-Label Opportunities
Beyond direct use in healthcare facilities, SteriBest Sterilization Trays are also available for manufacturers seeking private-label sterilization tray solutions. This makes SteriBest an attractive option for companies looking to expand their sterile processing product portfolios with a customizable, 510(k)-cleared tray system. Interested parties can contact Mastel Surgical (搜索) directly for customized quotes.
About Mastel Surgical
Mastel Surgical (搜索) is a provider of ophthalmic surgical products and sterile processing solutions for healthcare professionals and facilities across North America. Founded in 1981, the company supports surgical precision, instrument protection, and dependable reprocessing workflows through high-quality products and responsive customer service. Mastel operates as part of Pacific Surgical (搜索), a Canadian-based family of healthcare companies committed to bringing progressive products and service solutions to customers globally.