Carina Medical, LLC
United StatesFDA applicant, unverified
- Devices
- 4
What Carina Medical, LLC makes
Carina Medical, LLC manufactures the INTDose and INT Contour devices, which are designed for intrathecal drug delivery systems used in pain management and neurological conditions. INTDose appears to be a programmable pump system for precise medication dosing, while INT Contour is likely a catheter or connector component for intrathecal administration.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s portfolio is regulated in the United States, where these products are intended for use.
Catalogue
- Registry: GUDID
- Registry: GUDID
INTDose Ref K213137
Regimes: 510(k) Registry: 510(k)INT Contour Ref K212274
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 081070086
- [email protected]
- Phone
- +1-434-284-1073
Frequently asked questions
How many devices does Carina Medical, LLC have in the registry?
The registry currently lists 4 devices for Carina Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carina Medical, LLC's devices?
Among its 4 most recently registered devices, Carina Medical, LLC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Carina Medical, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Carina Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Carina Medical, LLC in the registry?
The most recently registered devices listed for Carina Medical, LLC include INTContour 1.6.3, INTDose 1.6.3, INTDose and INT Contour.