George Courey, Inc.
CanadaFDA applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What George Courey, Inc. makes
George Courey, Inc. manufactures reusable, non-medicated surgical procedure kits, sterilization wrappers, and surgical gowns designed for general surgical use. These products are intended for single-use protection and packaging of sterile instruments and supplies in operating room environments.
The company’s portfolio is regulated under FDA Class II devices and is listed in the FDA’s 510(k) and UDI registries. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
GCI Sterilization Wrappers Ref K250321
Regimes: 510(k) Registry: 510(k)GCI Surgical Gown Ref K233571
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 202156303
FDA establishments
- George Courey Inc Montreal Quebec · CA FEI 3015068387
Frequently asked questions
How many devices does George Courey, Inc. have in the registry?
The registry currently lists 5 devices for George Courey, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list George Courey, Inc.'s devices?
Among its 5 most recently registered devices, George Courey, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do George Courey, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for George Courey, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from George Courey, Inc. in the registry?
The most recently registered devices listed for George Courey, Inc. include SRI Surgical P620500-68992, SRI Surgical P620501-68992, SRI Surgical P74-119-3-68992 and GCI Sterilization Wrappers.
Which FDA establishments are linked to George Courey, Inc.?
1 FDA establishment is linked to George Courey, Inc. in the registry; they are listed on the company page.