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-220D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBS-771A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-950B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-230D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-280A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-915D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBM-700A	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-910A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSS-680	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-270A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-615D	FDA UDI	Class I	Active
Epinaut	C60013820	FDA UDI	Class II	Active
Imedicom Saw Blade	KLM-970A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-200C	FDA UDI	Class I	Unknown
Imedicom Saw Blade	SBM-761A	FDA UDI	Class I	Active
Ezx	BRXTL60B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-712D	FDA UDI	Class I	Active
EZX Blade	BRXTB680	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-433A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-200A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-200D	FDA UDI	Class I	Active
Ezx	BR EZX Kit 06	FDA UDI	Class I	Active
Brasseler EZX	BRITL059	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-200A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-960B	FDA UDI	Class I	Active
Ezx	BRELL054	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB610NS	FDA UDI	Class I	Active
Synth™ Plus	HCPE-SR10	FDA UDI	Class II	Active
Synth™ Plus Bilateral	SYNTH-SPB32	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSR-514D	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-970D	FDA UDI	Class I	Active
Ezx	BR EZX Kit 21	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B2MN2-15	FDA UDI	Class II	Active
Imedicom Saw Blade	KDS-960A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-920D	FDA UDI	Class I	Active
Imedicom Saw Blade	PAO-100B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-200C	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-250C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-350	FDA UDI	Class I	Active
Ezx	BRXTL37A	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-960B	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-970B	FDA UDI	Class I	Active
Ezx	BR EZX Kit 19	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-433A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-200A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-220B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-750D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-260C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-515D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-770	FDA UDI	Class I	Active

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