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510(k) Data Aggregation
K Number
K023658Device Name
STERILIZATION CASES AND TRAYS
Manufacturer
CARR METAL PRODUCTS, INC.
Date Cleared
2003-03-25
(145 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
CARR METAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 °C for a 4-minute minimum plus a minimum of 15 minutes drying time.
Device Description
Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.
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K Number
K972138Device Name
CARR RIGID CONTAINER SYSTEM
Manufacturer
CARR METAL PRODUCTS, INC.
Date Cleared
1997-11-13
(160 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
CARR METAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days.
Device Description
A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together.
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