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
Imedicom Saw Blade	BDS-401A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-612	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-920C	FDA UDI	Class I	Active
Synth™ Plus	CDS-CP1/ CDS-CFS1	FDA UDI	Class II	Active
Ezx	EZX System 02	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-411D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-270	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-950A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-930A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-960C	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB390NS	FDA UDI	Class I	Active
Brasseler EZX	BRXTL54A	FDA UDI	Class I	Active
Ezx	EZX Kit 18	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB480	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-200B	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB7	FDA UDI	Class II	Active
Imedicom Saw Blade	BSO-230D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-711	FDA UDI	Class I	Active
Brasseler EZX	BRXTL47B	FDA UDI	Class I	Active
Ezx	XTL46A	FDA UDI	Class I	Active
Medinaut Max	BMA-W10	FDA UDI	Class I	Unknown
Imedicom Saw Blade	BSN-270D	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-950B	FDA UDI	Class I	Active
Leopard	MMW-1000	FDA UDI	Class I	Active
Ezx	BRXLT54B	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-940A	FDA UDI	Class I	Active
Leopard	MH305	FDA UDI	Class I	Active
Ezx	BRXTL41B	FDA UDI	Class I	Active
Imedicom Saw Blade	SBA-760A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-910D	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-915C	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-980A	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CA1	FDA UDI	Class I	Active
Imedicom Saw Blade	PLM-100A	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-900C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-214	FDA UDI	Class I	Active
EZX Blade	XTB530	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-480	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-790	FDA UDI	Class I	Active
Ezx	XTL63B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-415D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-380D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-690D	FDA UDI	Class I	Active
EZX Blade	BRXTB480	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-280C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NBA-128	FDA UDI	Class I	Active
Brasseler EZX	BRITL036	FDA UDI	Class I	Active
Ezx	XTL62B	FDA UDI	Class I	Active
Leopard	YC1000	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-400A	FDA UDI	Class I	Active

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