SURETEX LIMITED - BRANCH

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, Synthetic (MOL) (6) Condom (HIS) (4)

Premarket Exempt

No

Clear

SKYN - 00070907000090 Catalog Number :

Device Description : SKYN ELITE 46CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 46

SKYN - 00070907000144 Catalog Number :

Device Description : SKYN ELITE LARGE 36CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 36

SKYN - 00070907000151 Catalog Number :

Device Description : SKYN ELITE EXTRA LUBE 36CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 36

SKYN - 00070907000168 Catalog Number :

Device Description : SKYN SELECTION 36CT (ORIGINAL, EXCITATION, ELITE EXTRA LUBE & ELITE)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 36

SKYN - 00070907000175 Catalog Number :

Device Description : SKYN SELECTION 12CT (ORIGINAL, EXCITATION, ELITE EXTRA LUBE AND ELITE)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 12

SKYN - 00070907000182 Catalog Number :

Device Description : SKYN SELECTION (ORIGINAL, EXCITATION, ELITE EXTRA LUBE & ELITE)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 24

LIFESTYLES - 00070907000199 Catalog Number :

Device Description : LIFESTYLES PLEASURE COLLECTION 12CT (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, LIFESTYLES PLEASURE COLLECTION 12CT (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTRA RIBBED AND FLAVORS & COLORS)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907000212 Catalog Number :

Device Description : LIFESTYLES PLEASURE COLLECTION (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTRA LIFESTYLES PLEASURE COLLECTION (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTRA RIBBED, FLAVORS & COLORS)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 36

LIFESTYLES - 00070907000229 Catalog Number :

Device Description : LIFESTYLES PREMIUM PACK 12CT (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTRA RIBBED)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907000243 Catalog Number :

Device Description : LIFESTYLES STYLES COLLECTION VARIETY PACK (ULTRA SENSITIVE, ULTRA SENSITIVE PLAT LIFESTYLES STYLES COLLECTION VARIETY PACK (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTRA THIN)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

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