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510(k) Data Aggregation

    K Number
    K072747
    Device Name
    UNIDUS MAGNUM MALE LATEX CONDOM
    Manufacturer
    UNIDUS CORP.
    Date Cleared
    2007-11-15

    (49 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIDUS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    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 205mm, nominal flat width 57mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dression material. This condom is designed to conform to established. national and international voluntary standards including ASTM D3492 and ISO 4074.
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    K Number
    K033541
    Device Name
    LONG LOVE CONDOM
    Manufacturer
    UNIDUS CORP.
    Date Cleared
    2003-12-23

    (43 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIDUS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDUS Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    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 0.06mm. It is either lubricated with silicone or non-lubricated; with cornstarch as a dressing material, and Benzocaine (an over-the-counter drug generally recognized as safe and effective by the USFDA) placed inside the condom for desensitizing the male genitals. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
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    K Number
    K023129
    Device Name
    UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
    Manufacturer
    UNIDUS CORP.
    Date Cleared
    2002-12-13

    (85 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIDUS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    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, nominal thickness 0.06mm and colored pink, yellow, green or black. 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 ISO 4074.
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    K Number
    K023175
    Device Name
    UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)
    Manufacturer
    UNIDUS CORP.
    Date Cleared
    2002-12-13

    (81 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIDUS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    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, nominal thickness 0.06mm and is colored. It is lubricated with silicone containing flavoring, 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 ISO 4074.
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    K Number
    K023176
    Device Name
    UNDUS MALE LATEX CONDOM (WITH FLAVORING)
    Manufacturer
    UNIDUS CORP.
    Date Cleared
    2002-12-13

    (81 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIDUS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    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 0.06mm. It is lubricated with silicone containing one of five flavors (strawberry, mint, vanilla, banana, or chocolate) 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 ISO 4074.
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    K Number
    K023059
    Device Name
    UNIDUS MALE LATEX CONDOM
    Manufacturer
    UNIDUS CORP.
    Date Cleared
    2002-12-12

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIDUS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    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 0.06mm. 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 ISO 4074.
    Ask a Question

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