Dermaclip Us, L.L.C.

Dermaclip Us, L.L.C. specializes in skin-closure adhesive strips, such as the DermaClip and DermaQuik lines. These devices are designed to close wounds, lacerations, or minor surgical incisions as an alternative to traditional sutures or staples. Their primary purpose is to facilitate wound healing in post-operative or trauma care settings.

Dermaclip Us, L.L.C. is headquartered in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under Class I medical devices, they are subject to general controls (e.g., labeling, manufacturing practices) but do not require pre-market approval. The FDA’s Unique Device Identifier (UDI) database lists these products, ensuring transparency and traceability in the U.S. market.

Dermaclip Us, L.L.C.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices in the U.S. This inclusion helps ensure compliance with FDA requirements for traceability and identification of Class I products like skin-closure adhesive strips. The UDI system is mandatory for most medical devices marketed in the U.S.

All of Dermaclip Us, L.L.C.’s devices fall under FDA Class I classification, meaning they pose minimal risk and are governed by general controls (e.g., good manufacturing practices, proper labeling). Class I devices typically require less stringent pre-market review than higher-risk categories, as their safety and effectiveness are considered well-established through experience or design. This classification applies to skin-closure adhesive strips like DermaClip and DermaQuik.