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U.S. Department of Health and Human Services

Product Classification

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Device hydrogel spacer
Definition To temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent to reduce the radiation dose delivered to the anterior rectum.
Physical State Synthetic, absorbable polyethylene glycol (PEG)-based hydrogel supplied in a single use tray
Technical Method Injected in tissue found between the rectum and prostate. The injected liquid solidifies creating a space between the rectum and prostate during radiation therapy to protect vulnerable tissue. It gradually liquifies and is absorbed.
Target Area Between the prostate and the rectum
Review Panel Radiology
Product CodeOVB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible