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Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

FDA product code PEB · 9 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.5300
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2006-10-13 – 2022-02-11

A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.

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