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	BRXTLSB3765	FDA UDI	Class I	Active
MEDINAUT Kyphoplasty System	MKB20	FDA UDI	Class II	Active
Brasseler EZX	BREZG101	FDA UDI	Class I	Unknown
Ezx	BREZX510	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CA2 / MIX-EX2B	FDA UDI	Class I	Active
Brasseler EZX	BRITL037	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-250B	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-220D	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-970B	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-950C	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB590	FDA UDI	Class I	Active
Brasseler EZX	BRXTL60A	FDA UDI	Class I	Active
Synth™ Cds	SYNTH-CDS-WPP1	FDA UDI	Class II	Active
Synth™ Plus	SYNTH-SPU18	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSM-310	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-790-5	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-T2MN2-15	FDA UDI	Class II	Active
Imedicom Saw Blade	KAO-940D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-210A	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB640NS	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PICD-SP1	FDA UDI	Class II	Active
Imedicom Saw Blade	BAO-433A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-240B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-414	FDA UDI	Class I	Active
Ezx	BR EZX Kit 15	FDA UDI	Class I	Active
Brasseler EZX	BRXTL46B	FDA UDI	Class I	Active
EZX Blade	BRXTB630	FDA UDI	Class I	Active
Epinaut	C31013820	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSM-410	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB490	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-T2MN2-10	FDA UDI	Class II	Active
Synth™ Plus Bilateral	SYNTH-SPB6	FDA UDI	Class II	Active
Imedicom Saw Blade	BAO-220D	FDA UDI	Class I	Active
Ezx	BRELP041	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB570NS	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-511D	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-920C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-250	FDA UDI	Class I	Active
EZX Blade	BRXTB690	FDA UDI	Class I	Active
Ezx	BREZX550	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-960D	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-210B	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-110 Series	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-470A	FDA UDI	Class I	Active
Brasseler EZX	BRXST2000 Plus	FDA UDI	Class I	Active
Ezx	BRXTL62A	FDA UDI	Class I	Active
EZX Blade	BRXTB650	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-260D	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 17	FDA UDI	Class I	Active
Ezx	EZX Kit 15	FDA UDI	Class I	Active

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