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FDA product code HDT

Device, Intrauterine, Contraceptive And Introducer

Obstetrics/GynecologyClass 321 CFR 884.5360Implantable
US regulatory classifications
US Product Code (FDA)
HDT
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 884.5360
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.