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) (2) Lubricant, Personal (NUC) (1)

Premarket Exempt

Clear

LIFESTYLES - 00070907000731 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE 2CT.

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 2

LIFESTYLES - 00070907000786 Catalog Number :

Device Description : LIFESTYLES CLOSER CONNECTION 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907000809 Catalog Number :

Device Description : LIFESTYLES CLOSER CONNECTION 10CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

LIFESTYLES - 00070907000823 Catalog Number :

Device Description : LIFESTYLES CLOSER CONNECTION 24CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 24

SKYN - 00070907000861 Catalog Number :

Device Description : SKYN SNUG FIT 12CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 12

SKYN - 00070907001028 Catalog Number :

Device Description : SKYN Classic Pack 2CT (SKYN ORIGINAL)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 2

Lifestyles - 00070907015032 Catalog Number :

Device Description : Lifestyles Ultra Lube Plus 3 ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

Lifestyles - 00070907017036 Catalog Number :

Device Description : Lifestyles Ultra Sensitive 3 ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907018033 Catalog Number :

Device Description : LIFESTYLES ULTRA LUBRICATED W/SPL 3CT

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

Skyn - 00070907024416 Catalog Number :

Device Description : Skyn Aqua Feel Personal Lubricant

Device Class : 2

Duns Number: 672044515

Premarket Exempt : No

Product Code : NUC

Prescription Use : No

Device Count : 1

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