Question 1

What types of medical devices does Micro-tech USA manufacture?

Accepted Answer

Micro-tech USA specializes in single-use and reusable accessories for endoscopic and surgical procedures. Their portfolio includes items like endoscope channel support kits, insufflation tubing sets, valve kits for endoscope channels, cleaning utensils for surgical instruments, bite blocks, and reusable Bovie cords. These products are designed to assist in preparation, cleaning, and operation during procedures, ensuring compatibility with endoscopy and surgical workflows.

Question 2

Where is Micro-tech USA based, and what regulatory jurisdiction does it operate under?

Accepted Answer

Micro-tech USA is based in the United States. Their devices are intended for use within the U.S. regulatory framework, meaning they comply with FDA requirements applicable to medical devices in that jurisdiction. This includes classification under FDA’s Class I and Class II categories, which determine the level of regulatory oversight based on risk.

Question 3

Which regulatory registries or databases list Micro-tech USA’s devices?

Accepted Answer

Micro-tech USA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices, ensuring traceability and transparency in the regulatory and healthcare systems. This listing helps healthcare providers and regulators verify the identity of the devices.

Question 4

How are Micro-tech USA’s devices classified by regulatory authorities?

Accepted Answer

Micro-tech USA’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification is determined by the device’s intended use and potential risk to patients.

Device	Model / Reference	Registries	Class	Status
4-Piece Valve Kit	BW01-FUJ4-F7	FDA UDI	Class II	Active
Endoscopy Kit - Basic + Gowns	KT1A0007A	FDA UDI	Class I	Active
Auxiliary Water Connector	BW01-FUJA	FDA UDI	Class II	Active
4-Piece Valve Kit	BW01-PEN4	FDA UDI	Class II	Active
Single End Channel Attached Valve Brush	MDBR1B0015K	FDA UDI	Class I	Active
Double Ended Valve Brush	MDBR1B0005A	FDA UDI	Class I	Active
Air/Water Channel Cleaning Adapter	BW01-OLYC	FDA UDI	Class I	Active
Breathe-EZ	MDBB1AY002A	FDA UDI	Class I	Active
Air/Water Channel Cleaning Adapter	BW01-FUJC-F7	FDA UDI	Class I	Active
ESD Specimen Tray	ESDT-909	FDA UDI	Class I	Active
CO2 Source Tubing Adapter Fuji GW100	BW02-CO2CONFJ	FDA UDI	Class I	Active
In-Line Suction Polyp Trap	MDPT1A0002A	FDA UDI	Class II	Active
CO2 Source Tubing Adapter Olympus UCR	BW02-CO2CONOLY	FDA UDI	Class I	Active
Air/Water Bottle CO2 Tubing	BW02-OLYC02	FDA UDI	Class II	Active
Double Ended Valve Brush + Double Ended Channel Brush	MDBR1B0014A	FDA UDI	Class I	Active
Jacket Biopsy Valve	MD-B-BV02	FDA UDI	Class II	Active
Scope Tip Protector	BW03-DTPL	FDA UDI	Class I	Active
4-Piece Valve Kit	BW01-FUJ4-F56	FDA UDI	Class II	Active
Coloshield Procedure Drape	COL-7055-50	FDA UDI	Class II	Active
Endoscopy Kit - Basic	MDKT1A0001A	FDA UDI	Class I	Active
CO2 Source Tubing Filter Adapter Olympus	BW02-CO2TUBAOLY	FDA UDI	Class II	Active
3-Piece Valve Kit	BW01-PEN3	FDA UDI	Class II	Active

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