Giltech Plus, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Giltech Plus, Inc. makes
Giltech Plus, Inc. manufactures wound care dressings, including hydrogel skin dressings for moist wound environments, transparent dressings for monitoring healing sites, and connecting tube sets for drainage applications.
The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) device categories, with some listed via the 510(k) pathway. These devices are intended for use in the United States.
Catalogue
Giltech Plus Hydrogel Skin Dressing Ref K992094
Regimes: 510(k) Registry: 510(k)Giltech Plus Connecting Tube Set Ref K983624
Regimes: 510(k) Registry: 510(k)Giltech Plus Transparent Dressing Ref K992005
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Giltech Plus, Inc. have in the registry?
The registry currently lists 3 devices for Giltech Plus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Giltech Plus, Inc.'s devices?
Among its 3 most recently registered devices, Giltech Plus, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Giltech Plus, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Giltech Plus, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Giltech Plus, Inc. in the registry?
The most recently registered devices listed for Giltech Plus, Inc. include GILTECH PLUS HYDROGEL SKIN DRESSING, GILTECH PLUS CONNECTING TUBE SET and GILTECH PLUS TRANSPARENT DRESSING.