Product code PBP
- Device name
- Rectal Insert
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Acts as a barrier to the passage of fecal matter through the rectum.
- Source
- FDA openFDA device classification dataset