Question 1

What types of medical devices does Durasafe Inc. manufacture?

Accepted Answer

Durasafe Inc. specializes in manufacturing non-powdered vinyl examination and treatment gloves. These gloves are primarily designed for medical use, including surgical and procedural applications, to provide barrier protection for healthcare professionals during patient care.

Question 2

Where is Durasafe Inc. based?

Accepted Answer

Durasafe Inc. is based in the United States. The company’s headquarters and operations are located within the country.

Question 3

Which regulatory registries list Durasafe Inc.’s devices?

Accepted Answer

Durasafe Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States.

Question 4

How are Durasafe Inc.’s devices classified under FDA regulations?

Accepted Answer

Durasafe Inc.’s devices are classified as Class I medical devices under FDA regulations. This classification applies to products that pose minimal risk and typically require less stringent premarket review.

Device	Model / Reference	Registries	Class	Status
Durasafe	2302	FDA UDI	Class I	Active
Durasafe	2303	FDA UDI	Class I	Active
Durasafe	2304	FDA UDI	Class I	Active
Durasafe	2305	FDA UDI	Class I	Active

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