Question 1

What types of medical devices does Fortune Medical Instrument Corp. manufacture?

Accepted Answer

Fortune Medical Instrument Corp. specializes in silicone-based drainage devices. Their portfolio includes closed-wound drains (such as flat drains and capillary luminal drains), single-use suction/irrigation tubing, urinary drainage solutions (including indwelling urethral balloon catheters and suprapubic drainage catheters), pleural and biliary drainage systems, and centesis drainage receptacles. They also produce specialized kits for endoscopic drainage procedures.

Question 2

Where is Fortune Medical Instrument Corp. based?

Accepted Answer

Fortune Medical Instrument Corp. is based in the United States. As a manufacturer, they operate within the country’s regulatory framework for medical devices, ensuring compliance with applicable standards for drainage and catheter products.

Question 3

Which regulatory registries list Fortune Medical Instrument Corp.’s devices?

Accepted Answer

Fortune Medical Instrument Corp.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify their products, including silicone drainage tubes, catheters, and specialized drainage kits, under the FDA’s regulatory oversight.

Question 4

How are Fortune Medical Instrument Corp.’s devices classified under FDA regulations?

Accepted Answer

Fortune Medical Instrument Corp.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.

Device	Model / Reference	Registries	Class	Status
Silicone Vac-Drain Kit	2014-9410	EUDAMEDFDA UDI	Class I	Active
Silicone Round Drain Kit	2015-9218	FDA UDI	Class I	Active
Rystora Silicone Scar Gel	SGA01501	EUDAMEDFDA UDI	Class I	Active
Rystora® Scar Sheets	SA042501	EUDAMEDFDA UDI	Class I	Active
FixPad Anchoring Device	1800-0005	EUDAMEDFDA UDI	Class I	Active
Silicone Penrose Drain Tube	2010-0712	FDA UDI	Class I	Active
Silicone Drainage Tube	65-040055	FDA UDI	Class I	Active
Silicone Y Drainage Tube	1920-0020	FDA UDI	Class II	Active
Silicone 2-way Foley Balloon Catheter, Female (Standard Balloon)	1824-0522	FDA UDI	Class II	Active
Silicone Flat Drain	2014-2071	FDA UDI	Class I	Active
Silicone Thoracic Drain, S Type	2018-0015	FDA UDI	Class I	Active
Silicone Drainage Tube	60-010015	FDA UDI	Class I	Active
Silicone Stomach Tube	2020-0004	FDA UDI	Class II	Active
Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon)	4890-8224	FDA UDI	Class II	Active
Silicone Flat Drain	2014-0071	FDA UDI	Class I	Active
Silicone T Drainage Set With Eyes	1910-8214	FDA UDI	Class II	Active
Silicone C.W.V. Reservoir	2013-0620	FDA UDI	Class I	Active
Silicone Endo Drain Kit (J Connector+Trocar)	2015-9615J	FDA UDI	Class I	Active
Silicone Drainage Tube	60-020030	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)	1890-8222	FDA UDI	Class II	Active
Silicone Drainage Tube	60-070100	FDA UDI	Class I	Active
Silicone Round Drain	2015-0320	FDA UDI	Class I	Active
Silicone Endo-Drain Kit	2015-9624	FDA UDI	Class I	Active
Laryngeal Mask Tube	1580-0060	FDA UDI	Class I	Active
Silicone Flat Drain	2014-0101	FDA UDI	Class I	Active
Silicone Drainage Tube	65-080120	FDA UDI	Class I	Active
Silicone Penrose Drain Tube	2010-0705	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Grooved Balloon)	1827-0012	FDA UDI	Class II	Active
Silicone Flat Drain	2014-2101	FDA UDI	Class I	Active
Silicone T Drainage Set	1910-8024	FDA UDI	Class II	Active
Silicone Drainage Tube	60-050090	FDA UDI	Class I	Active
Silicone Hubless Endo Drain Kit	2015-9710	FDA UDI	Class I	Active
Silicone Flat Drain	2014-0132	FDA UDI	Class I	Active
Silicone T Drainage Set	1910-8018	FDA UDI	Class II	Active
Silicone Penrose Drain Tube	2010-0708	FDA UDI	Class I	Active
Silicone Round Drain Kit	2015-9310	FDA UDI	Class I	Active
Silicone Flat Drain	2014-2102	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter (Integrated Balloon)	4890-0210	FDA UDI	Class II	Active
Silicone Drainage Tube	60-070110	FDA UDI	Class I	Active
Silicone Penrose Drain Tube	2010-5406	FDA UDI	Class I	Active
Silicone Hubless Endo Drain Kit (J Connector+Trocar)	2015-9721J	FDA UDI	Class I	Active
Silicone Drainage Tube	60-040058	FDA UDI	Class I	Active
Silicone Round Drain Kit	2015-9210	FDA UDI	Class I	Active
Silicone T Drainage Set With Eyes	1910-8224	FDA UDI	Class II	Active
Silicone Thoracic Drain, SF Type	2018-0116	FDA UDI	Class I	Active
Silicone Sump Drain Tube	2016-1214	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter, Female (Standard Balloon)	1823-0522	FDA UDI	Class II	Active
Silicone Drainage Tube	60-010020	FDA UDI	Class I	Active
Silicone Y Drainage Tube	1920-0014	FDA UDI	Class II	Active
Rystora® Scar Sheets	SA050712	EUDAMEDFDA UDI	Class I	Active

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