TISSUE SEAL L.L.C.

Tissue Seal LLC specializes in skin-approximation adhesives and dermal surgical adhesive/sealant applicators. These devices are primarily designed for wound closure and tissue sealing during surgical procedures, helping to bond skin layers or tissues securely. This reduces reliance on sutures or staples in specific medical applications.

Tissue Seal LLC is based in the United States. The company’s operations and regulatory compliance are aligned with U.S. medical device standards.

Tissue Seal LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices under U.S. regulatory oversight, ensuring transparency and traceability for healthcare providers and authorities.

Tissue Seal LLC’s devices fall under the FDA’s Class II classification. This category applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness without requiring the stringent pre-market approval process of Class III devices.