Question 1

What types of medical devices does Prime Medical LLC manufacture?

Accepted Answer

Prime Medical LLC specializes in two primary device categories: non-slip back pads for operating tables, which help secure patients during surgical procedures, and freestanding patient positioners designed for single-use in procedural settings. These devices are engineered to enhance patient stability and procedural workflow.

Question 2

Where is Prime Medical LLC based?

Accepted Answer

Prime Medical LLC is headquartered in the United States. The company’s location influences its regulatory compliance with U.S. and EU standards, particularly for devices listed in both the FDA’s UDI system and EUDAMED.

Question 3

Which regulatory registries list Prime Medical LLC’s devices?

Accepted Answer

Prime Medical LLC’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system, which tracks devices marketed in the U.S. Listing in these systems ensures traceability and compliance with respective regional regulations.

Question 4

How are Prime Medical LLC’s devices classified under medical device regulations?

Accepted Answer

Prime Medical LLC’s devices fall under Class I classification, the lowest risk category in the medical device regulatory framework. This classification applies to products like non-slip back pads and single-use positioners, which pose minimal risk to patients and typically require fewer pre-market controls before commercialization.

Device	Model / Reference	Registries	Class	Status
Prime Medical LLC	SS100	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-PED	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-K9	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-2	FDA UDI	Class I	Active
Prime Medical LLC	LHP100	FDA UDI	Class I	Active
Prime Medical LLC	WCF100	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-1S-21	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-K2-21	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-K5	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-1-21	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-K1	FDA UDI	Class I	Active
Prime Medical LLC	BBPPP	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-3S	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-W2	FDA UDI	Class I	Active
Prime Medical LLC	AAR100	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-K7	FDA UDI	Class I	Active
Prime Medical LLC	LAC100	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-K3	FDA UDI	Class I	Active
Prime Medical LLC	SS50	FDA UDI	Class I	Active
Prime Medical LLC	PrimePadPlus-2S	FDA UDI	Class I	Active
Prime Medical LLC	PrimePad-K10	FDA UDI	Class I	Active
PrimePad-1	PrimePad-1S	EUDAMEDFDA UDI	Class I	Active
PrimePad-1	PrimePad-2	EUDAMEDFDA UDI	Class I	Active
PrimePad-1	PrimePad-1	EUDAMEDFDA UDI	Class I	Active

Prime Medical LLC

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