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	ITL039	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-920A	FDA UDI	Class I	Active
Medinaut-V	IVP-NP4	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-311	FDA UDI	Class I	Active
Brasseler EZX	BRXST2000	FDA UDI	Class I	Active
Zaguar	BH301	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PIBE-15	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSR-680D	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-940D	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-970D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-480D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-250D	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB660NS	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB43	FDA UDI	Class II	Active
Imedicom Saw Blade	BPO-220A	FDA UDI	Class I	Active
EZX Blade	BRXTB510	FDA UDI	Class I	Active
Medinaut Max	BMA-D40	FDA UDI	Class I	Unknown
Imedicom Saw Blade	BBO-230A	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B2N10-10S	FDA UDI	Class II	Active
Brasseler EZX	BRXTL38B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-250D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-411	FDA UDI	Class I	Active
Ezx	BRXTL48A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-220A	FDA UDI	Class I	Active
Ezx	XST2000 PLUS	FDA UDI	Class I	Active
Zaguar	BRMKL-100	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB15	FDA UDI	Class II	Active
Imedicom Saw Blade	KPO-915A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-200C	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU10	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSM-614D	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU2-B1D1MN2-10	FDA UDI	Class II	Active
Imedicom Saw Blade	BDO-240B	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB530NS	FDA UDI	Class I	Active
Ezx	BRELP048	FDA UDI	Class I	Active
Ezx	EZX Kit 03	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-431A	FDA UDI	Class I	Active
Brasseler EZX	BRITL061	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-230C	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-200B	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-270D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBS-750A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-210A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-680D	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB630	FDA UDI	Class I	Active
Ezx	BRXTL58A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-410A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-220B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-220C	FDA UDI	Class I	Active
Synth™ Bes	SYNTH BES20	FDA UDI	Class II	Unknown

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