Product code OQY
- Device name
- Intrauterine Tamponade Balloon
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- provides temporary control or reduction of postpartum uterine bleeding
- Source
- FDA openFDA device classification dataset