Question 1

What types of medical devices does Northfield Medical Manufacturing, LLC primarily manufacture?

Accepted Answer

Northfield Medical Manufacturing, LLC specializes in single-use medical equipment/instrument drapes. These drapes serve as sterile barriers to protect clinical fields during surgical and procedural environments, helping to minimize contamination risks. The company’s focus is on maintaining sterile conditions in healthcare settings.

Question 2

Where is Northfield Medical Manufacturing, LLC based?

Accepted Answer

Northfield Medical Manufacturing, LLC is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those related to manufacturing, quality control, and distribution.

Question 3

How are Northfield Medical Manufacturing, LLC’s devices classified by regulatory authorities?

Accepted Answer

Northfield Medical Manufacturing, LLC’s devices are classified as FDA Class II medical devices. This classification typically applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as sterile drapes used in surgical settings.

Question 4

Are Northfield Medical Manufacturing, LLC’s devices listed in any regulatory registries?

Accepted Answer

Yes, Northfield Medical Manufacturing, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability in the healthcare supply chain.

Device	Model / Reference	Registries	Class	Status
Northfield Medical Manufacturing	51847	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51846	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51852	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51848	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51850	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51857	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51859	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51858	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51856	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51851	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51845	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51842	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51855	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51849	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51854	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51843	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51844	FDA UDI	Class II	Active
Northfield Medical Manufacturing	51853	FDA UDI	Class II	Active

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