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510(k) Data Aggregation
K Number
K071783Device Name
VERSAPOD (TM) INSTRUMENT TRAYS
Manufacturer
CONTAINMED, INC.
Date Cleared
2008-09-09
(435 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
CONTAINMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ContainMed, Inc. VersaPod™ Instrument Trays organize, protect, and transport medical instruments during prevacuum steam sterilization and subsequent storage. They do not maintain sterility unless used in conjunction with an FDA-cleared and legally marketed sterilization wrap. This device has not been validated for sterilization of instruments that are porous or have lumens.
Prevacuum Steam Cycle Parameters: 132°C, 4 minutes Drying: 45 minutes
Device Description
ContainMed VersaPod™ Instrument Trays consist of an anodized aluminum base with handles and latches and an anodized aluminum cover. Bases have the following external dimensions: 510mm (length) x 250mm (width) x 40mm. 60mm, or 82mm (depth). An optional anodized aluminum insert trav is available for use with the 82mm deep base only. Bases, covers, and insert trays are highly perforated to facilitate steam sterilant penetration. Anodized aluminum placard, and silicone rubber mat and instrument holding accessories (with stainless steel mounting hardware), are available to identify, organize, and protect the contents during use.
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