Search Results
Found 1 results
510(k) Data Aggregation
K Number
K123234Device Name
ERMIS STERILIZATION CONTAINER SYSTEM
Manufacturer
Date Cleared
2013-07-05
(263 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
ERMIS MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ERMIS Sterilization Container System is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, ¾ Size, ½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters.
The containers are reusable devices designed to be used with the following sterilization cycle parameters:
Pre Vacuum cycle: 4 minutes 132°C (270°F) Drying Time minimum 20 minutes
3 minutes 135°C (273°F) Drying Time minimum 16 minutes
Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles
Device Description
Ermis Medizintechnik Sterilization Container Systems are reusable devices intended to allow sterilization of enclosed medical devices and to maintain sterility of the enclosed devices until used.
- Interchangeable components within the different sizes (Full size, ¼ size, ½ size, Wide Body, Den-. tal, Mini, Flat).
- Containers are available with perforated and non-perforated bottom and perforated lids. .
- Safety lids are available for 1/1 size, 3/4 size and 1/2 size. Safety lids protect filters during storage . and/or transportation. The Lids are not intended to be used during sterilization.
- The lids are equipped with a silicone based gasket. .
- All containers incorporate a filter system to be used with Ermis disposable paper filters without . chemical indicator.
- To ensure effective sterilization and organization of sterilized goods, wire and screen baskets are . available.
Ask a Question
Ask a specific question about this device
Page 1 of 1