ISSAWRAP INC

Address:17339 Tramonto Dr.,Pacific Palisades,CA,90272,US

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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) (1)

Premarket Exempt

Clear

P.S. - 00860001852400 Catalog Number :

Device Description : This condom is made of a natural latex sheath, which completely covers the erect This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180 mm, nominal width 52 mm, and nominal thickness 0.045mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and IS0 407. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections.

Device Class :

Duns Number: 029021726

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 12

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