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) (2)

Premarket Exempt

Clear

LIFESTYLES - 00070907207376 Catalog Number :

Device Description : ZERO EXTRA LUBRICATED

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907208106 Catalog Number :

Device Description : LIFESTYLES TURBO 10 CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

LIFESTYLES - 00070907208724 Catalog Number :

Device Description : LIFESTYLES ULTRA TRIAL 26CT - contains Ultra Sensitive, Ultra Ribbed, Ultra Studded

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 26

LIFESTYLES - 00070907209103 Catalog Number :

Device Description : EVERLAST INTENSE 10 CT. 2 DZ.

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

LIFESTYLES - 00070907209325 Catalog Number :

Device Description : LIFESTYLES BARE BACK 10CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 10

SKYN - 00070907209363 Catalog Number :

Device Description : LIFESTYLES SKYN EXTRA STUDDED 2DZ 10S

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 10

LIFESTYLES - 00070907209370 Catalog Number :

Device Description : LIFESTYLES ULTRA RIBBED 12 CT.

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

LIFESTYLES - 00070907209387 Catalog Number :

Device Description : LIFESTYLES ULTRA STUDDED 12 CT.

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

SKYN - 00070907209394 Catalog Number :

Device Description : SKYN EXTRA STUDDED 22CT

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : MOL

Prescription Use : No

Device Count : 22

LIFESTYLES - 00070907209417 Catalog Number :

Device Description : LIFESTYLES ULTRA TRIAL 12+1ct (Contains Ultra Sensitive, Ultra Ribbed and Ultra LIFESTYLES ULTRA TRIAL 12+1ct (Contains Ultra Sensitive, Ultra Ribbed and Ultra Studded + 1 vibrating ring)

Device Class :

Duns Number: 672044515

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 13

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