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) (6) Condom, Synthetic (MOL) (4) Lubricant, Personal (NUC) (2)

Premarket Exempt

Clear

Skyn - 00070907024423 Catalog Number :

Device Description : Skyn All Night Long Personal Lubricant

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : NUC

Prescription Use : No

Device Count : 1

LIfestyles - 00070907026250 Catalog Number :

Device Description : LIFESTYLES PLEASURE COLLECTION 30CT- CONTAINS SKYN ELITE, SKYN ORIGINAL, ULTRA S LIFESTYLES PLEASURE COLLECTION 30CT- CONTAINS SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE PLATINUM, ULTRA SENSITIVE AND FLAVORS & COLORS

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL, HIS

Prescription Use : No

Device Count : 30

LIFESTYLES - 00070907030004 Catalog Number :

Device Description : LIFESTYLES PLEASURE COLLECTION 36CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA LIFESTYLES PLEASURE COLLECTION 36CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE PLATINUM, ULTRA SENSITIVE AND ASSORTED FLAVORS)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL, HIS

Prescription Use : No

Device Count : 36

Lifestyles - 00070907031032 Catalog Number :

Device Description : Lifestyles Snugger Fit 3ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

Lifestyles - 00070907041031 Catalog Number :

Device Description : Lifestyles Ultra Ribbed 3ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

SKYN - 00070907073032 Catalog Number :

Device Description : LIFESTYLES SKYN ORIGINAL 3S CIR

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 3

SKYN - 00070907074039 Catalog Number :

Device Description : SKYN ELITE LARGE 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 3

Excite - 00070907079010 Catalog Number :

Device Description : SKYN EXCITE GEL 15ML

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : NUC

Prescription Use : No

Device Count : 1

Lifestyles - 00070907091036 Catalog Number :

Device Description : Lifestyles Ultra Thin 3ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907098035 Catalog Number :

Device Description : LIFESTYLES KYNG 3S (LIFESTYLES KING 3CT)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

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