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510(k) Data Aggregation
K Number
K141826Device Name
FLASHPAK STERILIZATION CONTAINER SYSTEM
Manufacturer
Date Cleared
2015-04-02
(269 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SYMMETRY MEDICAL INC- MANCHESTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
FlashPak® Model/Maximum Instrument Load Weight Recommendation:
9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg)
9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg)
9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg)
9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)
Device Description
The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle.
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