Question 1

What types of medical devices does Life Instrument Corporation manufacture?

Accepted Answer

Life Instrument Corporation specializes in reusable surgical instruments primarily used in orthopaedic and spinal procedures. Their portfolio includes bone curettes for smoothing bone surfaces, rongeurs for cutting or removing bone, retractors (both hand-held and self-retaining) for holding back tissue, elevators for lifting bone or tissue, and open-surgery dissectors for precise tissue separation. These instruments are designed to enhance precision and efficiency during bone and joint surgeries.

Question 2

Where is Life Instrument Corporation based?

Accepted Answer

Life Instrument Corporation is based in the United States. The company’s headquarters and manufacturing operations are located within the country, though specific locations are not provided in the available data.

Question 3

Which regulatory registries list Life Instrument Corporation’s devices?

Accepted Answer

Life Instrument Corporation’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system in the United States. These registries help track and monitor medical devices for regulatory compliance and transparency.

Question 4

How are Life Instrument Corporation’s devices classified under EU regulations?

Accepted Answer

Life Instrument Corporation’s devices are classified under EU Class I and Class II regulations. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, reusable surgical instruments like rongeurs or retractors may fall into Class II due to their role in invasive procedures, while lower-risk items like certain dissectors might qualify for Class I. Classification determines the regulatory requirements for market authorization.

Question 5

Are Life Instrument Corporation’s devices reusable, and does that affect their classification?

Accepted Answer

Yes, many of Life Instrument Corporation’s devices are designed for reuse, such as bone curettes, rongeurs, retractors, and elevators. Reusability can influence classification because it impacts factors like sterilization processes, maintenance requirements, and associated risks. For instance, reusable instruments that enter sterile body cavities (e.g., spinal or orthopaedic tools) may be classified as higher risk (Class II) due to the need for rigorous cleaning and validation to prevent infection or complications. Classification ensures appropriate regulatory oversight based on these factors.

Device	Model / Reference	Registries	Class	Status
Life Instruments	826-0017-0	FDA UDI	Class I	Active
Life Instruments	830-0702-0	FDA UDI	Class I	Active
Life Instruments	713-9501-1C	FDA UDI	Class I	Active
Life Instruments	831-1506-1TC	FDA UDI	Class I	Active
Life Instruments	745-1007-0-1	FDA UDI	Class I	Active
Life Instruments	748-1040-1C	FDA UDI	Class I	Active
Life Instruments	775-1812-0	FDA UDI	Class I	Active
Life Instruments	765-1004-0-2	FDA UDI	Class I	Active
Life Instruments	649-2540-5	FDA UDI	Class I	Active
Life Instruments	719-1008-1C	FDA UDI	Class I	Active
Life Instruments	795-0505-1	FDA UDI	Class I	Active
Life Instruments	795-0612-1	EUDAMEDFDA UDI	Class I	Active
Life Instruments	714-9506-2	FDA UDI	Class I	Active
Life Instruments	765-1309-3	EUDAMEDFDA UDI	Class I	Active
Life Instruments	748-1065-2	EUDAMEDFDA UDI	Class I	Active
Life Instruments	830-1002-0ABC	FDA UDI	Class I	Active
Life Instruments	791-0011-1C	FDA UDI	Class I	Active
Life Instruments	746-1020-0C	EUDAMEDFDA UDI	Class I	Active
Life Instruments	710-1803-0-1	FDA UDI	Class I	Active
Life Instruments	741-0503-1C	FDA UDI	Class I	Active
Life Instruments	743-1000-2-1	FDA UDI	Class I	Active
Life Instruments	765-1812-2C	FDA UDI	Class I	Active
Life Instruments	790-1071-0	FDA UDI	Class I	Active
Life Instruments	703-1202-0	FDA UDI	Class I	Active
Life Instruments	720-1310-1	FDA UDI	Class I	Active
Life Instruments	714-1000-1U	FDA UDI	Class I	Active
Life Instruments	746-1250-3	EUDAMEDFDA UDI	Class I	Active
Life Instruments	714-1000-0U	FDA UDI	Class I	Active
Life Instruments	838-1204-0R	FDA UDI	Class I	Active
Life Instruments	834-0912-0	FDA UDI	Class I	Active
Life Instruments	748-0060-2	FDA UDI	Class I	Active
Life Instruments	714-1140-1UB	EUDAMEDFDA UDI	Class I	Active
Life Instruments	791-0008-1R	FDA UDI	Class I	Active
Life Instruments	712-0010-1	FDA UDI	Class I	Active
Life Instruments	649-2070-0-1	FDA UDI	Class I	Active
Life Instruments	744-2000-T	FDA UDI	Class I	Active
Life Instruments	748-1010-0	FDA UDI	Class I	Active
Life Instruments	510-1502-3S-1	FDA UDI	Class I	Active
Life Instruments	748-7518-0CS	FDA UDI	Class I	Active
Life Instruments	830-9003-0	FDA UDI	Class I	Active
Life Instruments	831-1003-0TC	FDA UDI	Class I	Active
Life Instruments	713-9502-4C	FDA UDI	Class I	Active
Life Instruments	832-0903-1-2	FDA UDI	Class I	Active
Life Instruments	710-1504-3UT	FDA UDI	Class I	Active
Life Instruments	714-1120-2U-1	FDA UDI	Class I	Active
Life Instruments	711-1514-2	FDA UDI	Class I	Active
Life Instruments	830-1106-2	FDA UDI	Class I	Active
Life Instruments	732-1050-1	FDA UDI	Class I	Active
Life Instruments	710-1505-4S	FDA UDI	Class I	Active
Life Instruments	643-8570-0	FDA UDI	Class I	Active

Life Instrument Corporation

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