Global Health Solutions LLC
United StatesFDA applicant, unverified
- Devices
- 10
What Global Health Solutions LLC makes
Global Health Solutions LLC manufactures Hexagen Derm, a topical antimicrobial agent for skin applications, and the PolyPlex Wound Dressing, a hydrocolloid-based dressing designed for wound management and exudate absorption.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Hexagen Derm Ref K171191
Regimes: 510(k) Registry: 510(k)PolyPlex Wound Dressing Ref K160872
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 117588619
Frequently asked questions
How many devices does Global Health Solutions LLC have in the registry?
The registry currently lists 10 devices for Global Health Solutions LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Health Solutions LLC's devices?
Among its 10 most recently registered devices, Global Health Solutions LLC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Global Health Solutions LLC's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Global Health Solutions LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Global Health Solutions LLC in the registry?
The most recently registered devices listed for Global Health Solutions LLC include 2XChromosome (2X)200920PL, 2XChromosome 330201, 2XChromosome 329201 and 2XChromosome 328201.