FDA product code HDN
Dilator, Cervical, Expandable
Obstetrics/Gynecology·Class 3·21 CFR 884.4250
US regulatory classifications
- US Product Code (FDA)
- HDNView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 884.4250View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
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About this record
Dilator, Cervical, Expandable 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.
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.