PRIMERA PLASTICS, INC.

Primera Plastics, Inc. specializes in single-use eye splash shields. These devices are designed to protect patients' eyes from accidental splashes or debris during medical procedures, ensuring safety and hygiene in clinical settings.

Primera Plastics, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction.

Primera Plastics, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the supply chain.

Primera Plastics, Inc.’s eye splash shields fall under Class I classification by the FDA. This classification applies to devices posing minimal risk to patients, often exempt from strict pre-market approvals, but still subject to general controls like good manufacturing practices (GMP).