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	KDS-900D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-260D	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-270C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-514D	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-920A	FDA UDI	Class I	Active
Zaguar	BRMJ.3000	FDA UDI	Class I	Active
Brasseler EZX	BRITL050	FDA UDI	Class I	Active
EZX Blade	BRXTB730	FDA UDI	Class I	Active
Ezx	EZX2-C01	FDA UDI	Class I	Active
Ezx	BRXTL53A	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB580NS	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-960A	FDA UDI	Class I	Active
Brasseler EZX	BRXTL52A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-401A	FDA UDI	Class I	Active
Ezx	ITL048	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 26	FDA UDI	Class I	Active
Zaguar	BRBHC.100	FDA UDI	Class I	Active
Imedicom Saw Blade	PDS-120A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-580	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-433A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-390	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-930C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-380D	FDA UDI	Class I	Active
Ezx	ELP035	FDA UDI	Class I	Active
Imedicom Saw Blade	SBM-750A	FDA UDI	Class I	Active
Ezx	XTL61A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-220A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-431A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-770A	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-400A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-411D	FDA UDI	Class I	Active
Ezx	XST-A01	FDA UDI	Class I	Active
Zaguar	XTS580	FDA UDI	Class I	Active
Leopard	ISA-100S	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-460A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-910C	FDA UDI	Class I	Active
Medinaut-V	IVP-NP3	FDA UDI	Class I	Active
Ezx	BRXTL65B	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-940D	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-940D	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-920C	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-430A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-270B	FDA UDI	Class I	Active
Brasseler EZX	BRITL034	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 34	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-750	FDA UDI	Class I	Active
Ezx	BRXTL52A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-270B	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-950A	FDA UDI	Class I	Active
Ezx	EZX2-L01	FDA UDI	Class I	Active

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