SURETEX LIMITED

SURETEX LIMITED - BRANCH

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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) (7) Condom, Synthetic (MOL) (3)

Premarket Exempt

Clear

CONTEMPO - 00070907200681 Catalog Number :

Device Description : CONTEMPO HOT RIDER

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 8

CONTEMPO - 00070907200698 Catalog Number :

Device Description : CONTEMPO ROUGH RIDER 8CT

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 8

SKYN - 00070907201015 Catalog Number :

Device Description : SKYN ELITE 50CT TIN

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 50

SKYN - 00070907201114 Catalog Number :

Device Description : SKYN SENSATIONS 12CT- CONTAINS SKYN EXTRA STUDDED, COCKTAIL CLUB (PASSION DAIQUI SKYN SENSATIONS 12CT- CONTAINS SKYN EXTRA STUDDED, COCKTAIL CLUB (PASSION DAIQUIRI), SKYN ELITE, SKYN WARMING AND SKYN COOLING

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 12

LifeStyles Ultra Sensitive Platinum - 00070907201794 Catalog Number :

Device Description : LifeStyles Ultra Sensitive Platinum Condoms 12ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

SKYN - 00070907202074 Catalog Number :

Device Description : SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTR SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTRA LUBE, SKYN ELITE)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907202104 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE PLATINUM 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907202111 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE PLATINUM EXTRA LUBE 12CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907202128 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE 12CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907207369 Catalog Number :

Device Description : ZERO ORIGINAL

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

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