Tray, instrument

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Oticon Medical A Division of Audmet Australia

Klass:

Class I

Tillverkad av:

Oticon Medical AB Datavagen 37B, Askim, SE-436 32 Sweden

Terapiområde:

12143 - Tray, instrument

Terapeutiska indikationer:

The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use. The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles: Temperature 132?C (270?F) ? Exposure time 4 minutes minimum ? Dry for 20 minutes minimum. Temperature 134-137?C (273-278?F) ? Exposure time 3 minutes minimum ? Dry for 16 minutes minimum.

Bemyndigande status:

A

Tillstånd datum:

2014-06-28