Product code QXR

Device name: Vaginal Hydrogel Packing System
Medical specialty: Radiology
Device class: 2
Regulation number: 892.5735
Review panel: RA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN220052	BrachyGel Vaginal Hydrogel Packing System	Brachyfoam, Inc. D/B/A Advaray	2023-08-22

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00841439114582	BrachyGel Vaginal Hydrogel Packing System	MEDTEC, INC.	2024-05-23
10841439114589	BrachyGel Vaginal Hydrogel Packing System	MEDTEC, INC.	2024-05-23

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