Question 1

What types of medical devices does J&J Instruments, LLC manufacture?

Accepted Answer

J&J Instruments, LLC specializes in reusable dental and surgical instruments. Their product line includes manual dental scalers, dental surgical scissors, tooth extraction forceps, orthodontic pliers, periosteal elevators, suturing needle holders, and dental surgical probes. These devices are designed for use in dental and surgical procedures.

Question 2

Where is J&J Instruments, LLC based?

Accepted Answer

J&J Instruments, LLC is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

Question 3

Which regulatory registries list J&J Instruments, LLC’s devices?

Accepted Answer

J&J Instruments, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for medical devices authorized in the U.S., helping healthcare providers and regulators verify product details.

Question 4

How are J&J Instruments, LLC’s devices classified under FDA regulations?

Accepted Answer

J&J Instruments, LLC’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. Classification depends on factors like intended use and potential health impact.

Device	Model / Reference	Registries	Class	Status
J & J Instruments	16-559	FDA UDI	Class I	Active
J & J Instruments Inc	02-521	FDA UDI	Class I	Active
J&J Instruments	05-850	FDA UDI	Class I	Active
J & J Instruments	24-3090	FDA UDI	Class I	Active
J & J Instruments	41-1480	FDA UDI	Class I	Active
J&J Instruments	06-157	FDA UDI	Class I	Active
J & J Instruments	16-550	FDA UDI	Class I	Active
J&J Instruments	11-741	FDA UDI	Class I	Active
J&J Instruments	11-713	FDA UDI	Class I	Active
J & J Instruments	95-204	FDA UDI	Class I	Active
J&J Instruments	33-6150	FDA UDI	Class I	Active
J & J Instruments	62-1605	FDA UDI	Class I	Active
J & J Instruments	36-2360	FDA UDI	Class I	Active
Julius Wirth	603-001	EUDAMED	Class I	Active
Julius Wirth	102-009	EUDAMED	Class I	Active
Julius Wirth	603-004	EUDAMED	Class I	Active
Julius Wirth	502-003	EUDAMED	Class I	Active
Julius Wirth	732-003	EUDAMED	Class I	Active
Julius Wirth	726-011	EUDAMED	Class I	Active
Julius Wirth	725-017	EUDAMED	Class I	Active
Julius Wirth	206-001	EUDAMED	Class I	Active
Julius Wirth	604-002	EUDAMED	Class I	Active
Julius Wirth	501-012	EUDAMED	Class I	Active
Julius Wirth	730-006	EUDAMED	Class I	Active
Julius Wirth	609-003	EUDAMED	Class I	Active
Julius Wirth	605-007	EUDAMED	Class I	Active
Julius Wirth	203-002	EUDAMED	Class I	Active
Julius Wirth	722-002	EUDAMED	Class I	Active
Julius Wirth	201-003	EUDAMED	Class I	Active
Julius Wirth	721-003	EUDAMED	Class I	Active
Julius Wirth	504-004	EUDAMED	Class I	Active
Julius Wirth	704-005	EUDAMED	Class I	Active
Julius Wirth	502-001	EUDAMED	Class I	Active
Julius Wirth	602-001	EUDAMED	Class I	Active
Julius Wirth	501-016	EUDAMED	Class I	Active
Julius Wirth	725-008	EUDAMED	Class I	Active
Julius Wirth	734-002	EUDAMED	Class I	Active
Julius Wirth	721-005	EUDAMED	Class I	Active
Julius Wirth	501-002	EUDAMED	Class I	Active
Julius Wirth	203-007	EUDAMED	Class I	Active
Julius Wirth	405-040	EUDAMED	Class I	Active
Julius Wirth	725-014	EUDAMED	Class I	Active
Julius Wirth	301-008	EUDAMED	Class I	Active
Julius Wirth	101-002	EUDAMED	Class I	Active
Julius Wirth	725-023	EUDAMED	Class I	Active
Julius Wirth	730-008	EUDAMED	Class I	Active
Julius Wirth	506-004	EUDAMED	Class I	Active
Julius Wirth	725-019	EUDAMED	Class I	Active
Julius Wirth	405-016	EUDAMED	Class I	Active
Julius Wirth	405-034	EUDAMED	Class I	Active

J&J Instruments, LLC

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