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
Julius Wirth	202-002	EUDAMED	Class I	Active
Julius Wirth	603-005	EUDAMED	Class I	Active
Julius Wirth	101-001	EUDAMED	Class I	Active
Julius Wirth	105-002	EUDAMED	Class I	Active
Julius Wirth	402-004	EUDAMED	Class I	Active
Julius Wirth	732-004	EUDAMED	Class I	Active
Julius Wirth	725-013	EUDAMED	Class I	Active
Julius Wirth	501-008	EUDAMED	Class I	Active
Julius Wirth	501-005	EUDAMED	Class I	Active
Julius Wirth	608-002	EUDAMED	Class I	Active
Julius Wirth	405-012	EUDAMED	Class I	Active
Julius Wirth	701-002	EUDAMED	Class I	Active
Julius Wirth	702-002	EUDAMED	Class I	Active
Julius Wirth	203-009	EUDAMED	Class I	Active
Julius Wirth	730-001	EUDAMED	Class I	Active
Julius Wirth	301-010	EUDAMED	Class I	Active
Julius Wirth	203-017	EUDAMED	Class I	Active
Julius Wirth	724-002	EUDAMED	Class I	Active
Julius Wirth	203-005	EUDAMED	Class I	Active
Julius Wirth	402-008	EUDAMED	Class I	Active
Julius Wirth	731-005	EUDAMED	Class I	Active
Julius Wirth	505-004	EUDAMED	Class I	Active
Julius Wirth	724-001	EUDAMED	Class I	Active
Julius Wirth	727-001	EUDAMED	Class I	Active
Julius Wirth	706-002	EUDAMED	Class I	Active
Julius Wirth	206-008	EUDAMED	Class I	Active
Julius Wirth	405-014	EUDAMED	Class I	Active
Julius Wirth	405-001	EUDAMED	Class I	Active
Julius Wirth	602-002	EUDAMED	Class I	Active
Julius Wirth	405-044	EUDAMED	Class I	Active
Julius Wirth	209-001	EUDAMED	Class I	Active
Julius Wirth	725-010	EUDAMED	Class I	Active
Julius Wirth	405-035	EUDAMED	Class I	Active
Julius Wirth	725-002	EUDAMED	Class I	Active
Julius Wirth	203-013	EUDAMED	Class I	Active
Julius Wirth	703-002	EUDAMED	Class I	Active
Julius Wirth	101-004	EUDAMED	Class I	Active
Julius Wirth	605-005	EUDAMED	Class I	Active
Julius Wirth	405-030	EUDAMED	Class I	Active
Julius Wirth	502-006	EUDAMED	Class I	Active
Julius Wirth	730-002	EUDAMED	Class I	Active
Julius Wirth	501-007	EUDAMED	Class I	Active
Julius Wirth	208-003	EUDAMED	Class I	Active
Julius Wirth	502-002	EUDAMED	Class I	Active
Julius Wirth	725-026	EUDAMED	Class I	Active
Julius Wirth	701-006	EUDAMED	Class I	Active
Julius Wirth	301-009	EUDAMED	Class I	Active
Julius Wirth	102-008	EUDAMED	Class I	Active
Julius Wirth	405-036	EUDAMED	Class I	Active
Julius Wirth	706-004	EUDAMED	Class I	Active

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