Ardent Production Development
Country not established
- Devices
- 2
What Ardent Production Development makes
Ardent Production Development manufactures non-Gamma-2 sterilized surgical drapes and gowns, including the Ardent Futura and Ardent Non Gamma-2 70 variants, designed for single-use in sterile field applications.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Ardent Futura Non Gamma-2 Ref K964775
Regimes: 510(k) Registry: 510(k)Ardent Non Gamma-2 70 Ref K964192
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ardent Production Development have in the registry?
The registry currently lists 2 devices for Ardent Production Development. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ardent Production Development's devices?
Among its 2 most recently registered devices, Ardent Production Development has devices listed in FDA 510(k) (2 devices).
What risk classes do Ardent Production Development's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ardent Production Development's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ardent Production Development in the registry?
The most recently registered devices listed for Ardent Production Development include ARDENT FUTURA NON GAMMA-2 and ARDENT NON GAMMA-2 70.