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Operating Room Innovations, Inc.

Country not established

Devices
32

What Operating Room Innovations, Inc. makes

Operating Room Innovations, Inc. manufactures single-use surgical drapes designed for use in operating rooms, including the ORI and Modular Toga systems. These products are intended to provide sterile barriers during surgical procedures to maintain a controlled environment for patients and staff.

The company’s portfolio is classified under FDA’s Class II regulatory category and is listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The products are developed and distributed from the United States.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

DUNS number
080246656
Phone
716-681-0866

Frequently asked questions

How many devices does Operating Room Innovations, Inc. have in the registry?

The registry currently lists 32 devices for Operating Room Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Operating Room Innovations, Inc.'s devices?

Among its 32 most recently registered devices, Operating Room Innovations, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Operating Room Innovations, Inc.'s devices fall under?

Among its 32 most recently registered devices, the classes recorded for Operating Room Innovations, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Operating Room Innovations, Inc. in the registry?

The most recently registered devices listed for Operating Room Innovations, Inc. include Specialty Anterior Hip Drape ORI-SDL-DAHIP, Specialty Lower Extremity Drape ORI-SDL-LEAD, Universal Upper Extremity Drape ORI-SDL-UPXD and SF-3L Solofit AAMI III SMS Gown Large.

Generated automatically from registry data and not verified by a human reviewer.