TTK HEALTHCARE LIMITED

Address:12, K P Natham Road,,Puducherry,IN

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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) (2)

Premarket Exempt

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SKORE BULBOUS DOTS AND RIBS - 08906007131711 Catalog Number :

Device Description : The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bu The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat ended, fully textured, transparent male condom. It meets the requirements as specified in ASTM D 3492 standard for rubber latex contraceptives (Male condoms). The Skore bulbous dots and ribs natural rubber latex condoms are used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Class :

Duns Number: 675476406

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 3

Sustain Natural Extra Large Ribs and Dots. - 08906007132084 Catalog Number :

Device Description : The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. I The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bulbous teat ended, fully textured, transparentmale condom. it meets the requirements as specified in ASTM D3492 standard for rubber latex contraceptives (Male Condoms). TheSustain Natural Extra large Ribs and Dots natural rubber latex condoms are used for contraception and for prophylactic purposes (toHelp prevent pregnancy and the transmission of sexually transmitted diseases)

Device Class :

Duns Number: 675476406

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 1

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