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
MEDINAUT Plus Kyphoplasty System	PICD-CA1/ PICD-NDD1	FDA UDI	Class II	Active
Imedicom Saw Blade	BAS-260B	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-210C	FDA UDI	Class I	Active
Leopard	ISA-100	FDA UDI	Class I	Active
Imedicom Saw Blade	PBO-110A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBC-730A	FDA UDI	Class I	Active
Imedicom Saw Blade	PMS-110J	FDA UDI	Class I	Active
Imedicom Saw Blade	PMS-100J	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-915A	FDA UDI	Class I	Active
EZX Blade	BRXTB620	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-430A	FDA UDI	Class I	Active
Zaguar	BRHC-100	FDA UDI	Class I	Active
EZX Blade	XTB650	FDA UDI	Class I	Active
EZX Blade	BRXTB500	FDA UDI	Class I	Active
Zaguar	BRMJ-2000	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-270C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-511D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-210	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSS-380	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-200D	FDA UDI	Class I	Active
Leopard	MH303	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-461B	FDA UDI	Class I	Active
Ezx	BRXTL43A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-915C	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-H02	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-950D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-970C	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB700	FDA UDI	Class I	Active
EZX Blade	XTB700	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB560NS	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B2MN2-15	FDA UDI	Class II	Active
Brasseler EZX	BREZX530	FDA UDI	Class I	Active
Ezx	BRXST1000TB3	FDA UDI	Class I	Active
Ezx	EZH200	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-250A	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-260A	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PIBE-SR10	FDA UDI	Class II	Active
Ezx	BRXTL42B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-200D	FDA UDI	Class I	Active
Zaguar	BRBDW-100	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-210C	FDA UDI	Class I	Active
Ezx	BRELL043	FDA UDI	Class I	Active
Ezx	ITL038	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-210D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-230D	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CA3 / MIX-EX3T	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-451B	FDA UDI	Class I	Active
Ezx	BRXTL60B	FDA UDI	Class I	Active
Imedicom Saw Blade	PPO-110A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBC-700A	FDA UDI	Class I	Active

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