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	733-001	EUDAMED	Class I	Active
Julius Wirth	506-001	EUDAMED	Class I	Active
Julius Wirth	704-001	EUDAMED	Class I	Active
Julius Wirth	606-002	EUDAMED	Class I	Active
Julius Wirth	403-001	EUDAMED	Class I	Active
Julius Wirth	725-009	EUDAMED	Class I	Active
Julius Wirth	405-020	EUDAMED	Class I	Active
Julius Wirth	726-006	EUDAMED	Class I	Active
Julius Wirth	205-005	EUDAMED	Class I	Active
Julius Wirth	402-006	EUDAMED	Class I	Active
Julius Wirth	405-039	EUDAMED	Class I	Active
Julius Wirth	501-010	EUDAMED	Class I	Active
Julius Wirth	405-038	EUDAMED	Class I	Active
Julius Wirth	206-004	EUDAMED	Class I	Active
Julius Wirth	207-002	EUDAMED	Class I	Active
Julius Wirth	203-015	EUDAMED	Class I	Active
Julius Wirth	301-011	EUDAMED	Class I	Active
Julius Wirth	507-002	EUDAMED	Class I	Active
Julius Wirth	405-021	EUDAMED	Class I	Active
Julius Wirth	102-005	EUDAMED	Class I	Active
Julius Wirth	725-016	EUDAMED	Class I	Active
Julius Wirth	205-003	EUDAMED	Class I	Active
Julius Wirth	203-020	EUDAMED	Class I	Active
Julius Wirth	405-025	EUDAMED	Class I	Active
Julius Wirth	737-002	EUDAMED	Class I	Active
Julius Wirth	725-011	EUDAMED	Class I	Active
Julius Wirth	726-002	EUDAMED	Class I	Active
Julius Wirth	701-010	EUDAMED	Class I	Active
Julius Wirth	405-007	EUDAMED	Class I	Active
Julius Wirth	704-002	EUDAMED	Class I	Active
Julius Wirth	701-003	EUDAMED	Class I	Active
Julius Wirth	503-004	EUDAMED	Class I	Active
Julius Wirth	405-023	EUDAMED	Class I	Active
Julius Wirth	504-001	EUDAMED	Class I	Active
Julius Wirth	202-003	EUDAMED	Class I	Active
Julius Wirth	206-009	EUDAMED	Class I	Active
Julius Wirth	735-004	EUDAMED	Class I	Active
Julius Wirth	604-003	EUDAMED	Class I	Active
Julius Wirth	605-001	EUDAMED	Class I	Active
Julius Wirth	705-007	EUDAMED	Class I	Active
Julius Wirth	732-005	EUDAMED	Class I	Active
Julius Wirth	405-018	EUDAMED	Class I	Active
Julius Wirth	206-010	EUDAMED	Class I	Active
Julius Wirth	734-001	EUDAMED	Class I	Active
Julius Wirth	206-003	EUDAMED	Class I	Active
Julius Wirth	603-006	EUDAMED	Class I	Active
Julius Wirth	506-003	EUDAMED	Class I	Active
Julius Wirth	501-020	EUDAMED	Class I	Active
Julius Wirth	736-012	EUDAMED	Class I	Active
Julius Wirth	701-005	EUDAMED	Class I	Active

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