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510(k) Data Aggregation
K Number
K093800Device Name
ROBINSON MEDSURG QUICKSCREW RACK
Manufacturer
Date Cleared
2010-06-16
(188 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
ROBINSON MEDSURG LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Robinson MedSurg QuickScrew Rack RCK24-143 is intended to organize, hold, and protect the QuickScrew screwdrivers for transport, storage, sterilization, and use during surgery. The subject instrument racks are suitable for use in prevacuum steam. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
Method: Prevacuum Steam Autoclave
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Drying Time: 60 minutes
Device Description
The Robinson MedSurg QuickScrew Rack RCK24-143 is an instrument rack for organizing, holding, and protecting reusable surgical instruments during transportation, storage, and sterilization. It is designed for adequate exposure of the trays' contents to sterilant during the sterilization process.
The Rack is made of anodized aluminum with polytherimide tube holders for the instruments and to allow for air and sterilant to flow through and around the rack.
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