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
Apronette, Standard Lead, 18" x 24"	69098-25	FDA UDI	Class I	Active
Wolf X-Ray	66084TC-23	FDA UDI	Class I	Active
Wolf X-Ray	65027TB-36	FDA UDI	Class I	Active
Wolf X-Ray	66083TC-30	FDA UDI	Class I	Active
Wolf X-Ray	68097TB-37	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Small	67086-42	FDA UDI	Class I	Active
Wolf X-Ray	68098LW-30	FDA UDI	Class I	Active
Wolf X-Ray	66079LW-39	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Large	67088-18	FDA UDI	Class I	Active
Apron and Vest, Ladies Large	66079-37	FDA UDI	Class I	Active
ADULT APRON BIB with COLLAR .3MM, Paw Print	75051-34	FDA UDI	Class I	Active
Wolf X-Ray	62021TB-14	FDA UDI	Class I	Active
Pro-Tek-To Pad	75057-42	FDA UDI	Class I	Active
Thyroid Collar No Lead, .25mm 5" X 27"	75056NL-39	FDA UDI	Class I	Active
Wolf X-Ray Easy Wrap Apron	65027TC-25	FDA UDI	Class I	Active
Wolf X-Ray	66077LW-39	FDA UDI	Class I	Active
Wolf X-Ray	63073TB-38	FDA UDI	Class I	Active
Wolf X-Ray	63011LW-16	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Small 22 X 33	62008-38	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Medium 24 X 39	62018-12	FDA UDI	Class I	Active
Wolf X-Ray Easy Wrap Apron	65027TC-36	FDA UDI	Class I	Active
Front Closing Spec. Procedure Apron, Standard Lead	68095-18	FDA UDI	Class I	Active
Child Panoramic Apron .25mm 24" X 27"	75062NL-37	FDA UDI	Class I	Active
APRON, BIB .25MM 24X26 Medium Blue	75050NL-16	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 22" X 37"	65025-35	FDA UDI	Class I	Active
Wolf X-Ray, Thyroid Collar Softex	75070-12	FDA UDI	Class I	Active
Apron and Vest, Ladies Large	66079-40	FDA UDI	Class I	Active
Apronette, Standard Lead, 12" x 12"	69095-30	FDA UDI	Class I	Active
Apron and Vest, Men's Medium, Standard Lead	66082-35	FDA UDI	Class I	Active
Film Flow Kopy Kat Duplicating Film, 6 X 12	18071	FDA UDI	Class I	Active
Pediatric Easy Wrap Apron, Small 10" X 27"	66001-16	FDA UDI	Class I	Active
Front Closing Spec. Procedure Apron, Standard Lead	68096-25	FDA UDI	Class I	Active
Burkhart Dental Supply	72720623	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Small	67086-34	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 24" X 42"	65023-41	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Large 24 X 42	62019-42	FDA UDI	Class I	Active
PureLife X-Ray Film	1200502	FDA UDI	Class I	Active
Film Dv-58 Silver D Adult Value Pak	18200E	FDA UDI	Class I	Active
Pediatric Easy Wrap Apron Light Weight, Small 10" X 27"	66001LW-34	FDA UDI	Class I	Active
Thyroid Collar No Lead, .25mm 5" X 27"	75056NL-18	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42	62021-34	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 24" X 40"	65021-35	FDA UDI	Class I	Active
Apron and Vest, Men's Xtra Large, Standard Lead	66084-22	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 22" X 37"	65025-16	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Small	67086-12	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Large	67088-14	FDA UDI	Class I	Active
Apron and Vest, Ladies Large	66079-35	FDA UDI	Class I	Active
Child Bib Apron With Attached Collar .25mm, 20" X 20"	75053NL-23	FDA UDI	Class I	Active
Apronette, Standard Lead, 12" x 24"	69097-42	FDA UDI	Class I	Active
Wolf X-Ray, Thyroid Collar Softex	75070-30	FDA UDI	Class I	Active

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