Chemo Mouthpiece, LLC
Country not established
- Devices
- 6
What Chemo Mouthpiece, LLC makes
Chemo Mouthpiece, LLC produces a single-use oral mucositis cryotherapy mouthpiece designed to reduce chemotherapy-induced mouth sores in patients undergoing cancer treatment. The device is applied to the oral mucosa before and during chemotherapy sessions to lower tissue temperature and minimize damage.
The company’s cryotherapy mouthpiece is authorised as a Class I and Class II medical device in the US, with submissions recorded under FDA 510(k) and FDA UDI registries. The device is listed under US regulatory frameworks and is manufactured in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Chemo Mouthpiece Ref K232917
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chemo Mouthpiece, LLC have in the registry?
The registry currently lists 6 devices for Chemo Mouthpiece, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chemo Mouthpiece, LLC's devices?
Among its 6 most recently registered devices, Chemo Mouthpiece, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Chemo Mouthpiece, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Chemo Mouthpiece, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Chemo Mouthpiece, LLC in the registry?
The most recently registered devices listed for Chemo Mouthpiece, LLC include Chemo Mouthpiece 100-1004, Chemo Mouthpiece 100-0004, Denta-Cool 100-0005 and Chemo Mouthpiece.