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Sign in to claim this brandOVATION INTERNATIONAL
US
Last updated May 23, 2026
What OVATION INTERNATIONAL makes
Ovation International manufactures single-use ophthalmic knives and reusable scalpel handles, as well as general-purpose surgical spatulas and lens spoons. These tools are designed for precision in eye surgery and general surgical procedures, including tissue manipulation and incision tasks.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer operates from 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 Ovation International manufacture?
Ovation International specializes in surgical instruments primarily used in ophthalmic (eye) and general surgery. Their product lineup includes single-use ophthalmic knives, reusable scalpel handles, general-purpose surgical spatulas, and lens spoons. These tools are designed for precision tasks like tissue manipulation, incision, and lens handling during surgical procedures.
Where is Ovation International based?
Ovation International is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, including those governing medical device manufacturing and distribution.
Which regulatory registries or databases list Ovation International’s devices?
Ovation International’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This database helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare supply chain.
How are Ovation International’s devices classified under FDA regulations?
Ovation International’s devices fall under Class I classification according to FDA regulations. This classification applies to low-risk medical devices that pose minimal potential harm to patients, such as basic surgical instruments like knives, spatulas, and lens spoons. Class I devices typically require general controls (e.g., good manufacturing practices) but may not need pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- 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
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- DUNS Number
- 879324241
Catalogue (162)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Opthalmic Spatula | OI-2287T-20G | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS69300 | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS6145 | FDA UDI | Class I | Active |
| Opthalmic Spatula | OI-2289S-25G | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS6401S | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS6564 | FDA UDI | Class I | Active |
| Opthalmic Spatula | OI-2289S-20G | FDA UDI | Class I | Active |
| Opthalmic Spoon | OI-3660T | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS6402S | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS6351 | FDA UDI | Class I | Active |
| Ophthalmic Knife | OVS6228DB | FDA UDI | Class I | Active |
| Opthalmic Spoon | OI-3662S | FDA UDI | Class I | Active |
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