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) (9) Condom, Synthetic (MOL) (1)

Premarket Exempt

Clear

LIFESTYLES - 00070907210109 Catalog Number :

Device Description : LIFESTYLES ULTRA THIN 10 CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

SKYN - 00070907211014 Catalog Number :

Device Description : LIFESTYLES SKYN EXTRA STUDDED 3CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 3

LIFESTYLES - 00070907212127 Catalog Number :

Device Description : LIFESTYLES MIXX 12 CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907212240 Catalog Number :

Device Description : LIFESTYLES MIXX 24 CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 24

Lifestyles - 00070907212721 Catalog Number :

Device Description : Lifestyles Ultra Trial 30 ct - contains Ultra Sensitive, Ultra Ribbed, Ultra Stu Lifestyles Ultra Trial 30 ct - contains Ultra Sensitive, Ultra Ribbed, Ultra Studded, and Ultra Lubricated

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 30

LIFESTYLES - 00070907216101 Catalog Number :

Device Description : LIFESTYLES CLMX 10 CT.

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

Lifestyles - 00070907217122 Catalog Number :

Device Description : Lifestyles Ultra Sensitive 12 ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

Lifestyles - 00070907217146 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE 14CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 14

LIFESTYLES - 00070907217467 Catalog Number :

Device Description : LIFESTYLES ULTRA SENSITIVE 40CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 40

Lifestyles - 00070907220283 Catalog Number :

Device Description : Lifestyles Zero 3 ct

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

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