BrachyGel Vaginal Hydrogel Packing System (BVHPS)

BrachyGel Vaginal Hydrogel Packing System (BVHPS)
BrachyGel Vaginal Hydrogel Packing System - RT-5300

A manual brachytherapy applicator specifically designed to be used in vaginal or transvaginal radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes vaginal applicators such as hollow needles or tubes, catheters, ovoids or tandems, used in manual brachytherapy applications.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QXR

Device Name: Vaginal Hydrogel Packing System

Device Class: 2

Physical State: Flexible container filled with hydrogel to create space in the vaginal cavity

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.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Placed in the vaginal cavity for radiation therapy treatment. The hydrogel material is injected into a flexible container, which creates space within the vaginal cavity to aid in the reduction of dose to adjacent pelvic organs during radiation therapy.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Vaginal cavity

Regulation Number: 892.5735

Third Party Flag: N

Medical Specialty: RA

Device Id: 10841439114589

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00841439114582

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00841439114582

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A