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Vaginal Hydrogel Packing System

Vaginal Hydrogel Packing System is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Vaginal Hydrogel Packing System
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QXR

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Class 2

21 CFR 892.5735

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Radiology

Device Characteristics

No

No

No

Not Eligible

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.