Question 1

What types of medical devices does IMEDICOM CO., LTD. manufacture?

Accepted Answer

IMEDICOM CO., LTD. specializes in surgical instruments and power tools for orthopaedic and bone procedures. Their product range includes single-use surgical saw blades (both sagittal and reciprocating), orthopaedic osteotome blades, sawing attachments for power tools, rechargeable battery-powered handpieces, electric motors for bone/joint surgery, and kits for balloon kyphoplasty and orthopaedic cement preparation. These devices are designed to assist in precise cutting, shaping, and cement delivery during surgical interventions.

Question 2

Where is IMEDICOM CO., LTD. based?

Accepted Answer

IMEDICOM CO., LTD. is headquartered in the United States. Their location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for devices intended for the U.S. market or global distribution.

Question 3

Which regulatory registries or databases list IMEDICOM CO., LTD.’s devices?

Accepted Answer

IMEDICOM CO., LTD.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model names, and regulatory classifications.

Question 4

How are IMEDICOM CO., LTD.’s devices classified under FDA regulations?

Accepted Answer

IMEDICOM CO., LTD.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as bone or joint procedures.

Question 5

What distinguishes IMEDICOM CO., LTD.’s single-use devices from their reusable counterparts?

Accepted Answer

IMEDICOM CO., LTD. offers single-use surgical saw blades and osteotome blades, which are designed for one-time use only. Single-use devices eliminate the need for sterilization between patients, reducing the risk of cross-contamination and ensuring consistent performance. This approach is particularly critical in orthopaedic surgery, where precision and sterility are paramount, as it simplifies inventory management and compliance with infection control protocols.

Device	Model / Reference	Registries	Class	Status
EZX Blade	XTB690	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-270B	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU40	FDA UDI	Class II	Active
Brasseler EZX Blade	BRXTB700	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-710D	FDA UDI	Class I	Active
Ezx	BRXST1000A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-400A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-350	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-220D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-930B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-650	FDA UDI	Class I	Active
Ezx	BRXST1000A	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-930A	FDA UDI	Class I	Active
Zaguar	XTS370	FDA UDI	Class I	Active
Imedicom Saw Blade	SBV-772A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-940C	FDA UDI	Class I	Active
Zaguar	BHL-100	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB610	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-915A	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 29	FDA UDI	Class I	Active
Ezx	XTL63A	FDA UDI	Class I	Active
Ezx	XZT1000	FDA UDI	Class I	Unknown
Ezx	BR EZX Kit 01	FDA UDI	Class I	Active
Ezx	EZX560	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-960C	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-230C	FDA UDI	Class I	Active
Brasseler EZX	BRITL055	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-915A	FDA UDI	Class I	Active
Ezx	EZX Kit 05	FDA UDI	Class I	Active
Ezx	XTL38B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-960C	FDA UDI	Class I	Active
Epinaut	L33011320	FDA UDI	Class II	Active
Ezx	BREZX540	FDA UDI	Class I	Active
Ezx	ITL3465	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-940C	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-960A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-910A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-760A	FDA UDI	Class I	Active
Zaguar	BRBDJ.100	FDA UDI	Class I	Active
Ezx	ITL063	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-230B	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-260C	FDA UDI	Class I	Active
Ezx	BRELP037	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B2MN2-10	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSR-315	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-280C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-670	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-315D	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-960A	FDA UDI	Class I	Active
MEDINAUT MAX Pro	BSH-100	FDA UDI	Class I	Active

IMEDICOM CO., LTD.

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