Gi Scientific, LLC
United StatesFDA applicant, unverified
- Devices
- 22
What Gi Scientific, LLC makes
Gi Scientific, LLC produces single-use and reusable cleaning tools designed for surgical instruments and endoscopes, including brushes and protective devices. Their portfolio also includes devices like the Venturi MicroDryer, Venturi Dry, and GIS Endoscopic Optical Lens, which are used for drying and maintaining optical clarity in endoscopic equipment. Additional offerings include the ScopeSeal Duodenoscope Protective Device, which is intended for duodenoscope protection during cleaning and reprocessing.
These devices are classified under FDA categories, with some falling under Class I and others under Class II. They are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, reflecting their regulatory compliance in the United States. The company operates within the regulatory framework of the US market.
Catalogue
Search and filter all 22 devicesCompany details
- DUNS number
- 075723383
- [email protected]
- Phone
- 5084943777
Frequently asked questions
How many devices does Gi Scientific, LLC have in the registry?
The registry currently lists 22 devices for Gi Scientific, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gi Scientific, LLC's devices?
Among its 22 most recently registered devices, Gi Scientific, LLC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (20 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Gi Scientific, LLC's devices fall under?
Among its 22 most recently registered devices, the classes recorded for Gi Scientific, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gi Scientific, LLC in the registry?
The most recently registered devices listed for Gi Scientific, LLC include Venturi Dry GI-FVDM-002-1, Venturi Dry GI-PVDL-001-1, Venturi Dry GI-PVDM-002-1 and Venturi Dry GI-OVDS-003-1.