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510(k) Data Aggregation

    K Number
    K092963
    Device Name
    GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2011-01-14

    (476 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    8-global® Blastocyst Fast Freeze Kit - Based on S3: - Media Intended for cryopreservation of human blastocysts. . 12-global® Blastocyst Fast Freeze Thawing Kit - Based on S3 - Media intended for the thawing and recovery of human blastocysts that . have been cryopreserved using the &-global® Blastocyst Fast Freeze Kit - Based on \$3.
    Device Description
    Not Found
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    K Number
    K092667
    Device Name
    GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2010-06-03

    (276 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Global DMSO Blastocyst Vitrification Kit: - Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts. Global DMSQ Blastocyst Vitrification Warming Kit - . Intended for the recovery and rehydration of vitrified human blastocysts - Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.
    Device Description
    Not Found
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    K Number
    K092578
    Device Name
    LIFEGLOBAL PROTEIN SUPPLEMENT
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2010-04-05

    (227 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeGlobal Protein Supplement is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.
    Device Description
    Not Found
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    K Number
    K083509
    Device Name
    LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2009-04-24

    (149 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeGlobal ® Human Serum Albumin (HSA) is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.
    Device Description
    Not Found
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    K Number
    K070689
    Device Name
    LG SPERM FREEZING
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2007-07-03

    (112 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.
    Device Description
    Not Found
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    K Number
    K020560
    Device Name
    WORKBENCH BY <GENX>
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2002-06-19

    (119 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Workbench will be used as an accessory item during assisted reproductive procedures.
    Device Description
    Not Found
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    K Number
    K962816
    Device Name
    SPERM PREPARATION MEDIA
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    1996-11-26

    (130 days)

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

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen.
    Device Description
    Sperm Preparation Media is a mineral essential media with glucose and penicillin. This product is provided in sterile bottles. This products as indicated in the label is For In Vitro Use Only.
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    K Number
    K963031
    Device Name
    GENXCATHETER
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    1996-10-21

    (77 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENX INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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