Question 1

What types of medical devices does Flow X-Ray Corp. manufacture?

Accepted Answer

Flow X-Ray Corp. specializes in radiation protection equipment for medical and dental imaging. Their product line includes lead-lined radiation shielding aprons, reusable patient shielding pads or drapes, dental X-ray film (both screen and non-screen types), and X-ray intensifying screens. These devices are designed to minimize radiation exposure for both healthcare professionals and patients during X-ray procedures.

Question 2

Where is Flow X-Ray Corp. based, and what regulatory regions do their devices serve?

Accepted Answer

Flow X-Ray Corp. is based in the United States. Their devices are intended for use in the US market and are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices regulated by the FDA. The company’s products comply with applicable US regulatory requirements for radiation shielding and imaging materials.

Question 3

Which regulatory registries or databases list Flow X-Ray Corp.’s devices?

Accepted Answer

Flow X-Ray Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to identify medical devices throughout their distribution and helps ensure traceability and regulatory compliance. This listing applies to all their products, which are classified as Class I devices.

Question 4

How are Flow X-Ray Corp.’s devices classified under medical device regulations?

Accepted Answer

Flow X-Ray Corp.’s devices are classified as Class I medical devices. Class I devices are generally considered to pose the lowest risk and often involve minimal regulation beyond general controls. This classification applies to their radiation shielding equipment, including aprons, drapes, and X-ray film, as these products are designed to protect against radiation exposure without requiring invasive procedures or significant risk.

Device	Model / Reference	Registries	Class	Status
Easy Wrap Apron, Lead .5mm 24" X 40"	65021-12	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42	62021-35	FDA UDI	Class I	Active
Apronette, Standard Lead, 18" x 24"	69098-39	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 25" X 40"	65026-18	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Small 22 X 33	62008-23	FDA UDI	Class I	Active
Wolf X-Ray Easy Wrap Apron	65021TC-39	FDA UDI	Class I	Active
Thyroid Collar	75060-41	FDA UDI	Class I	Active
Apronette, Standard Lead, 12" x 24"	69097-18	FDA UDI	Class I	Active
APRON, BIB .25MM 24X26 Beige	75050NL-23	FDA UDI	Class I	Active
Apron Bib .3mm 24x26/ Royal Blue	75050-20	FDA UDI	Class I	Active
Child Panoramic Apron .25mm 24" X 27"	75062NL-30	FDA UDI	Class I	Active
Apron and Vest, Men's Small, Standard Lead	66081-18	FDA UDI	Class I	Active
Thyroid Collar	75060-37	FDA UDI	Class I	Active
Apronette, Standard Lead, 12" x 24"	69097-38	FDA UDI	Class I	Active
Thyroid Collar .3mm 5" X 27"	75056-22	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Medium	67087-38	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 25" X 40"	65026-12	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 25" X 40"	65026-14	FDA UDI	Class I	Active
Wolf X-Ray Easy Wrap Apron	65023TC-18	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Large 24 X 42	62019-38	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 22" X 37"	65025-22	FDA UDI	Class I	Active
Minimax Bitewing TRX-3	20701	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Small 22 X 33	62008-22	FDA UDI	Class I	Active
Coat Apron, Lead .5mm 26 X 42	63013-14	FDA UDI	Class I	Active
Coat Apron, Lead .5mm 24 X 40	63001-40	FDA UDI	Class I	Active
Apron and Vest, Men's Xtra Large, Standard Lead	66084-14	FDA UDI	Class I	Active
Apron and Vest, Ladies Xtra Large	66080-25	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 26" X 42"	65027-20	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Large	67088-42	FDA UDI	Class I	Active
Easy Wrap Apron	65027TC-20	FDA UDI	Class I	Active
Wolf X-Ray Protective Gloves	12419	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42	62021-25	FDA UDI	Class I	Active
Henry Schein Dx-54	18035S	FDA UDI	Class I	Active
Film Cephalometric	31101	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Medium 24 X 39	62018-19	FDA UDI	Class I	Active
Coat Apron, Lead .5mm 25 X 40	63012-42	FDA UDI	Class I	Active
ADULT BIB APRON with COLLAR ..25mm, No Lead, Black	75051NL-25	FDA UDI	Class I	Active
Wolf X-Ray Easy Wrap Apron	65021TC-12	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 24" X 40"	65021-38	FDA UDI	Class I	Active
Coat Apron, Lead .5mm 24 X 42	63011-25	FDA UDI	Class I	Active
Apron and Vest, Ladies Xtra Large	66080-39	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, XX Large	67090-35	FDA UDI	Class I	Active
Apronette, Standard Lead, 12" x 24"	69097-20	FDA UDI	Class I	Active
Thyroid Collar No Lead, .25mm 5" X 27"	75056NL-22	FDA UDI	Class I	Active
ADULT APRON BIB with COLLAR .3MM, Burgundy	75051-18	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Large	67088-37	FDA UDI	Class I	Active
Front Closing Spec. Procedure Apron, Standard Lead	68097-38	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Large 24 X 42	62019-14	FDA UDI	Class I	Active
Front Closing Spec. Procedure Apron, Standard Lead	68097-36	FDA UDI	Class I	Active
Coat Apron, Lead .5mm 24 X 40	63001-38	FDA UDI	Class I	Active

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