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510(k) Data Aggregation
K Number
K131455Device Name
RESTORE MODULAR STERILIZATION TRAY SYSTEM
Manufacturer
RESTORE MEDICAL SOLUTIONS, INC.
Date Cleared
2013-08-30
(102 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
RESTORE MEDICAL SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses when used in conjunction with a FDA cleared sterilization wrap.
The Modular Sterilization Tray System may be used with common surgical instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds.
Reusable Medical Device Challenge Conditions
Minimum Inner Diameter: 1.8 mm
Maximum Length: 4 inches
Number of lumens: 2
High Vacuum (pre-vacuum, three pulse, standard):
Temp: 270° F
Exposure Time: 4 Minutes
Cycle Dry Time (wrapped): 20 Minutes (minimum)
Cool Time: Varies according to load contents
NOTE: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome.
Device Description
The Restore ™ Modular Sterilization Tray System is designed using materials that can be reused with steam sterilization methods. The Restore ™ system has an even distribution of holes in relation to its size for optimal steam penetration.
The basic system includes either a 10 x 20 x 4 inch or 10 x 10 x 4 inch aluminum tray with lids and a variety of insert tray assemblies and lids. The central function is an adjustable racking and multi-functioning stringer device, which is designed for the organization and alignment of surgical instruments for pre-sterilization cleaning decontamination, and sterilization cycles of surgical devices in healthcare facilities.
For the sterilization process, the tray system may be either wrapped in FDA-cleared sterilization wrap designed for this purpose or placed in a rigid container.
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