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510(k) Data Aggregation
K Number
K032445Device Name
THE ULTRA SYSTEM
Manufacturer
PROMEDICA, INC.
Date Cleared
2004-03-29
(234 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.
Device Description
The ULTRA SYSTEM is a reusable sterilization container system.
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K Number
K032813Device Name
THE ULTRA SYSTEM SP
Manufacturer
PROMEDICA, INC.
Date Cleared
2004-02-13
(157 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.
Device Description
Not Found
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