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510(k) Data Aggregation
K Number
K993535Device Name
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
Manufacturer
RILEY MEDICAL, INC.
Date Cleared
2001-12-07
(780 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
RILEY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Riley Medical MetaPak Multi-Purpose Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.
The Riley Medical MetaPak Multi-Purpose Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
Device Description
The Riley Medical MetaPak Multi-Purpose Instrument Tray (MetaPak Instrument Tray) is an instrument container consisting of a rectangular box base with a cover that fastens to the base using latches on the short ends. The following sizes of bases and lids are available:
- Tall hase and lid: 22" x 10" x 6" .
- Short base and lid: 22" x 10" x 4" .
- Extra long base and lid: 26" x 10" x 6" .
Insert trays can be stacked in the container base to increase the instrument-carrying capacity of the container. The following insert sizes are available:
- . Full insert: 21" x 9.5" x 2.5"
- Small insert: 10" x 9.5" x 2.5" t
Protective mats are available that can be placed on the insert trays and in the bottom of the container base to stabilize and protect the instruments. Slotted instrument bars and holders are also available to organize, stabilize, and protect the instruments in the container.
The MetaPak Instrument Tray is identical to the predicate MultiPak Instrument Tray, cleared for marketing as K944025, with the exception of a modification to the materials for the container base. The original MultiPak Instrument Tray container base was constructed entirely of Radel plastic. The MetaPak Instrument Tray container base will be offered in aluminum, stainless steel, and an aluminum/Radel combination with the long sides made of aluminum and short sides made of Radel plastic.
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