Dana Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Dana Products, Inc. makes
Dana Products manufactures reusable test packs and emulating indicators for validating steam sterilization processes. These include Bowie-Dick indicators, steam integrators, and reusable test packs designed for extended cycle testing (e.g., 10-minute extended cycles). The products are used in healthcare settings to ensure sterilization equipment performs correctly.
The company’s portfolio consists of Class II medical devices, all of which are cleared via the FDA’s 510(k) pathway. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Dana Reusable Test Pack For Steam Sterilization Ref K102761
Regimes: 510(k) Registry: 510(k)Reusable Test Pack For Dana Emulating Indicators Ref K110253
Regimes: 510(k) Registry: 510(k)Dana Reusable Test Pack Ref K133267
Regimes: 510(k) Registry: 510(k)Dana Emulating Indicator Ref K100891
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Steam Sterilization Intergrator Ref K012195
Regimes: 510(k) Registry: 510(k)Dana Reusable Test Pack For Steam Sterilization Ref K092944
Regimes: 510(k) Registry: 510(k)Dana Reusable Bi Test Pack Ref K130135
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dana Products, Inc. have in the registry?
The registry currently lists 9 devices for Dana Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dana Products, Inc.'s devices?
Among its 9 most recently registered devices, Dana Products, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Dana Products, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Dana Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dana Products, Inc. in the registry?
The most recently registered devices listed for Dana Products, Inc. include DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS, DANA REUSABLE TEST PACK FOR STEAM STERILIZATION, REUSABLE TEST PACK FOR DANA EMULATING INDICATORS and DANA REUSABLE TEST PACK.