KRISHNA IMPORTS INC

Krishna Imports Inc specializes in reusable ophthalmic surgical instruments. Their portfolio includes forceps for soft-tissue manipulation, ocular hooks and spatulas, irrigation/infusion/aspiration cannulas, suturing needle holders, corneal scissors, corneal markers, surgical handling forceps, and lacrimal punctum plugs. These devices are designed for precision in eye surgery procedures, ensuring reliability and sterility for repeated use.

Krishna Imports Inc is based in the United States. Since they manufacture reusable surgical instruments, their devices must comply with U.S. regulatory standards, including those set by the FDA. The company’s location ensures they operate within the jurisdiction of U.S. medical device regulations, which govern manufacturing, labeling, and post-market surveillance for reusable instruments.

Krishna Imports Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent, standardized identification for medical devices, enabling healthcare providers, regulators, and manufacturers to track and verify product details. Listing in the UDI system ensures traceability and compliance with FDA requirements for reusable ophthalmic instruments.

Krishna Imports Inc’s devices fall under FDA Class I and Unclassified (U) classifications. Class I generally includes low-risk devices that pose minimal potential harm, often requiring only general controls like good manufacturing practices. Unclassified (U) devices are those not yet assigned a specific risk class but still undergo FDA review to ensure safety and effectiveness. These classifications help determine the regulatory oversight and labeling requirements for each product.