MBU — Single-Use Internal Condom Class II
FDA product code MBU covers "Single-Use Internal Condom", a Class II medical device regulated under 21 CFR 884.5340. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- MBU
- Device Class
- Class II
- Regulation Number
- 884.5340
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.