Gel-Lite, LLC
Country not established
- Devices
- 1
What Gel-Lite, LLC makes
Gel-Lite, LLC manufactures various surgical and patient drapes designed to provide sterile barriers during medical procedures. These products are intended for use in operating rooms and clinical settings to maintain cleanliness and reduce contamination risks during surgery or patient care.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. These drapes are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Various Surgical Or Patient Drapes Ref K980210
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gel-Lite, LLC have in the registry?
The registry currently lists 1 device for Gel-Lite, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gel-Lite, LLC's devices?
Among its 1 most recently registered device, Gel-Lite, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Gel-Lite, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Gel-Lite, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gel-Lite, LLC in the registry?
The most recently registered devices listed for Gel-Lite, LLC include VARIOUS SURGICAL OR PATIENT DRAPES.