GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC

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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) (6)

Premarket Exempt

No Yes

Clear

The Keeper - 00787010222218 Catalog Number :

Device Description : The Keeper Menstrual Cup Size A

Device Class : 2

Duns Number: 948902387

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

The Keeper - 00787010222225 Catalog Number :

Device Description : The Keeper Menstrual Cup Size B

Device Class : 2

Duns Number: 948902387

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Moon Cup - 00788832000183 Catalog Number :

Device Description : Reusable non-latex menstrual cup

Device Class : 2

Duns Number: 948902387

Premarket Exempt : No

Product Code : HHE

Prescription Use : No

Device Count : 1

Moon Cup - 00788832000190 Catalog Number :

Device Description : Reusable menstrual cup, non-latex

Device Class : 2

Duns Number: 948902387

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

XO Flo - 00788832105505 Catalog Number :

Device Description : XO Flo Menstrual Cup

Device Class : 2

Duns Number: 948902387

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

XO Flo - 00788832105604 Catalog Number :

Device Description : XO Flo Mini

Device Class : 2

Duns Number: 948902387

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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