Nordion International, Inc.
Country not established
- Devices
- 2
What Nordion International, Inc. makes
Nordion International, Inc. manufactures radiation processing facilities, specifically the GAMMACELL 3000 ELAN and its earlier version (1.0), as well as the GAMMACELL 1000 ELITE (version 1.0). These devices are designed for high-dose irradiation of medical supplies, pharmaceuticals, and other materials requiring sterile or sterilized conditions.
The company’s portfolio is regulated under Class U devices in the United States, with relevant products listed via the FDA’s 510(k) pathway. Nordion International, Inc. is headquartered in the US.
Catalogue
Gammacell 3000 Elan Ref K952291
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nordion International, Inc. have in the registry?
The registry currently lists 2 devices for Nordion International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nordion International, Inc.'s devices?
Among its 2 most recently registered devices, Nordion International, Inc. has devices listed in FDA 510(k) (2 devices).
What are the newest devices from Nordion International, Inc. in the registry?
The most recently registered devices listed for Nordion International, Inc. include GAMMACELL 3000 ELAN and GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0.