21 CFR 884.5350 — Diaphragm, Contraceptive (And Accessories)

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5350

Identification

A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HDWDiaphragm, Contraceptive (And Accessories)243rd Party
MPTContraception Calculator21
Innolitics

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