FDA product code HDT
Device, Intrauterine, Contraceptive And Introducer
Obstetrics/Gynecology·Class 3·21 CFR 884.5360·Implantable
US regulatory classifications
- US Product Code (FDA)
- HDTView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 884.5360View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
Device characteristics
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
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About this record
Device, Intrauterine, Contraceptive And Introducer is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.