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Sign in to claim this brandFLEX OPERATING ROOM, INC
US
Last updated September 17, 2026
What FLEX OPERATING ROOM, INC makes
Flex Operating Room, Inc. manufactures single-use, sterile surgical drapes and instrument/equipment covers designed for operating room use. These include patient drapes and specialized covers for medical racks and equipment, such as the Dinamic OR Spine Rack Monitor Cover and Gerstner-labeled wide covers for surgical procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Flex Operating Room, Inc. manufacture?
Flex Operating Room, Inc. specializes in single-use, sterile surgical drapes and instrument/equipment covers. These include patient surgical drapes and specialized covers for operating room equipment, such as racks and monitors. Examples include the Dinamic OR Spine Rack Monitor Cover and Gerstner-labeled wide covers for surgical procedures.
Where is Flex Operating Room, Inc. based?
Flex Operating Room, Inc. is based in the United States. The company’s headquarters and manufacturing operations are located within the country.
Which regulatory registries list Flex Operating Room, Inc.’s devices?
Flex Operating Room, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance.
How are Flex Operating Room, Inc.’s devices classified under FDA regulations?
Flex Operating Room, Inc.’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as single-use sterile drapes and equipment covers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 5801 County Road 41, Farmington, NY, 14425
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3012966700
- DUNS Number
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Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dinamic OR Spine Rack Monitor Cover 60x64cm | Gerstner-Moncover-01A | FDA UDI | Class II | Active |
| Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 | 3000A-B | FDA UDI | Class II | Active |
| Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 | 2000B-B | FDA UDI | Class II | Active |
| Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 | 2000A-B | FDA UDI | Class II | Active |
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