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) (8) Condom, Synthetic (MOL) (3)

Premarket Exempt

Clear

LIFESTYLES - 00070907222102 Catalog Number :

Device Description : LIFESTYLES VIPER 10 CT.

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

Skyn - 00070907229811 Catalog Number :

Device Description : Skyn Elite 36 ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 36

SKYN - 00070907230039 Catalog Number :

Device Description : SKYN ELITE 12CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907230046 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE 36CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 36

LIFESTYLES - 00070907230077 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE PLATINUM EXTRA LUBE 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907230084 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907230213 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE PLATINUM 36CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 36

LIFESTYLES - 00070907230381 Catalog Number :

Device Description : LIFESTYLES PLEASURE COLLECTION 12CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA LIFESTYLES PLEASURE COLLECTION 12CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE PLATINUM, ULTRA SENSITIVE, ASSORTED FLAVORS)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL, HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907230398 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE BRAVO 12COUNT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907230404 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE BRAVO 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

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