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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hydrogel spacer
Definition The perirectal spacer is intended 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 of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.
Product CodeOVB
Regulation Number 892.5725
Device Class 2

Device Problems
Contamination during use 2
Disinfection or Sterilization Issue at User Location 2
No Known Device Problem 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Total Device Problems 7