OKAMOTO USA, INC.

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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

Condom (HIS) (10)

Premarket Exempt

No Yes

Clear

WINK - 00028373140109 Catalog Number :

Device Description : WINK Closer Condom (10ct box)

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

WINK - 00028373140246 Catalog Number :

Device Description : WINK Closer Condom (24ct box)

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 24

WINK - 00028373150030 Catalog Number :

Device Description : WINK Slider Condom (3ct box)

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

WINK - 00028373150108 Catalog Number :

Device Description : WINK Slider Condom (10ct box)

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

WINK - 00028373150245 Catalog Number :

Device Description : WINK Slider Condom (24ct box)

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 24

BEYOND SEVEN® CROWN® Condoms - 00028373200032 Catalog Number : 20003

Device Description : Natural rubber latex condom, lubricated, thin.

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

BEYOND SEVEN® CROWN® Condoms - 00028373200360 Catalog Number : 20036

Device Description : Natural rubber latex condom, lubricated, thin.

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 36

BEYOND SEVEN® CROWN® Condoms - 00028373201008 Catalog Number : 20100

Device Description : Natural rubber latex condom, lubricated, thin.

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 100

BEYOND SEVEN® CROWN® Condoms - 00028373204122 Catalog Number : 20412

Device Description : Natural rubber latex condom, lubricated, thin.

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

CROWN® Condoms - 00028373210000 Catalog Number : 21000

Device Description : Natural rubber latex condom, lubricated, thin.

Device Class :

Duns Number: 175752724

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 1008

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