Product code MBU
- Device name
- Single-Use Internal Condom
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5340
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.
- Source
- FDA openFDA device classification dataset