DOT INTERNATIONAL L3C

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cup, Menstrual (HHE) (1)

Premarket Exempt

Yes

Clear

Dot Cup - 00860499001908 Catalog Number :

Device Description : Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup p Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.

Device Class : 2

Duns Number: 111833424

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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