Saybrex Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Saybrex Intl., Inc. makes
Saybrex Intl., Inc. manufactures single-use surgical apparel, including isolation gowns, masks, caps, and sleeves, as well as bed sheets and pillow cases designed for medical settings.
These products are regulated under FDA 510(k) clearance, with most classified as Class I or Class II devices. The company’s items are listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Bed Sheet, Pillow Case Ref K884380
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Saybrex Intl., Inc. have in the registry?
The registry currently lists 2 devices for Saybrex Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Saybrex Intl., Inc.'s devices?
Among its 2 most recently registered devices, Saybrex Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Saybrex Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Saybrex Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Saybrex Intl., Inc. in the registry?
The most recently registered devices listed for Saybrex Intl., Inc. include SURGICAL APPAREL, ISOLATION GOWN, MASK, CAP, SLEEVE and BED SHEET, PILLOW CASE.