ANDRE GREGATE BRAGA INSTRUMENTOS LTDA

ANDRE GREGATE BRAGA INSTRUMENTOS LTDA specializes in reusable surgical instruments primarily for dental and orthopedic procedures. Their product lineup includes periosteal elevators, dental material application tools, scalpels, dental rongeurs, retractors, bone curettes, surgical screwdrivers, and dental dressing forceps. These instruments are designed for controlled environments, such as clinics or hospitals, and are intended for either single-patient or multi-patient use.

The company, ANDRE GREGATE BRAGA INSTRUMENTOS LTDA, is based in the US. While the company operates within the US regulatory framework, it is important to note that individual devices—not the company itself—must undergo authorization processes like FDA clearance or registration to be legally marketed in the US. The company’s devices are registered in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with US regulatory requirements.

Devices produced by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorized for use in the US market. The UDI system helps healthcare providers, regulators, and other stakeholders verify device details, including manufacturer information and regulatory classification.

All devices manufactured by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA fall under Class I regulatory classification in the US. Class I devices are generally considered to pose the lowest risk and typically require only general controls (such as registration, labeling, and manufacturing practices) to ensure safety and effectiveness. This classification applies to reusable surgical instruments like periosteal elevators, scalpels, and dental retractors, as outlined in the FDA’s regulatory framework.