Question 1

What types of medical devices does Vernacare Limited manufacture?

Accepted Answer

Vernacare Limited specializes in tissue extraction bags, which are used during medical procedures to collect and contain tissue samples. These devices are designed for surgical or diagnostic interventions, ensuring proper handling and containment of specimens.

Question 2

Where is Vernacare Limited based?

Accepted Answer

Vernacare Limited is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Question 3

Which regulatory registries list Vernacare Limited’s devices?

Accepted Answer

Vernacare Limited’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 traceability and compliance with regulatory requirements.

Question 4

How are Vernacare Limited’s devices classified by regulatory authorities?

Accepted Answer

Vernacare Limited’s tissue extraction bags fall under FDA Class II classification. This classification indicates a moderate level of risk, requiring specific regulatory controls to ensure safety and effectiveness before authorization.

Device	Model / Reference	Registries	Class	Status
nubert	24003US	FDA UDI	Class II	Active
nubert	24005	FDA UDI	Class II	Active
Bert®	24004	FDA UDI	Class II	Active
Bert®	24003DS	FDA UDI	Class II	Active

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