Isolyer Co.
Country not established
- Devices
- 1
What Isolyer Co. makes
Isolyer Co. manufactures sterile, non-woven barrier drapes designed for surgical and procedural isolation, including the ISOLYER (4X4, 8PLY) model. These products are intended to provide fluid-resistant protection during medical procedures to maintain sterile fields and reduce contamination risks.
The company’s portfolio is classified under FDA’s Class I medical devices and is subject to 510(k) clearance requirements. The ISOLYER drapes are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Isolyer (4X4, 8PLY) Ref K940755
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isolyer Co. have in the registry?
The registry currently lists 1 device for Isolyer Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isolyer Co.'s devices?
Among its 1 most recently registered device, Isolyer Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Isolyer Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Isolyer Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Isolyer Co. in the registry?
The most recently registered devices listed for Isolyer Co. include ISOLYER (4X4, 8PLY).