Osheru, L.L.C.

Osheru, L.L.C. specializes in single-use ophthalmic knives, which are surgical instruments designed specifically for eye procedures. Their product line includes devices like the Ziplyft, a disposable cutting tool intended for precision during ocular surgeries. These devices are tailored to reduce contamination risks and improve safety in clinical settings.

Osheru, L.L.C. is headquartered in the United States. Since the company’s devices are manufactured domestically, they fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA’s regulatory framework applies to ensure compliance with safety and performance standards for medical devices, including classification and listing requirements.

Osheru’s devices, such as the Ziplyft, are classified as FDA Class I. This classification is typically assigned to low-risk medical devices that pose minimal potential harm to patients. Class I devices often require less stringent regulatory oversight, but they must still meet basic safety and performance requirements. The classification helps streamline compliance while ensuring fundamental standards are met.

Yes, Osheru’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling better tracking, traceability, and transparency in the healthcare supply chain. This listing helps healthcare providers and regulators identify and verify the device’s details, such as manufacturer information and regulatory status.