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    K Number
    K052059
    Device Name
    IUI CATHETER, MODEL 9057
    Manufacturer
    INNTEC, INC.
    Date Cleared
    2005-11-22

    (116 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for intrauterine insemination.
    Device Description
    The InnTec IUI Catheter has been specifically designed for Intrauterine Inseminations. The over all Catheter length is 17.5cm, and tapers from 7 Fr. at the hub down to 5 Fr at the distal tip which is 5cm long. The tip is closed and smoothly rounded, eyelets are located at 180° from one another. Catheter internal volume is .07cc. Centimeter marks are printed at 6, 7, 8, 9, & 10cm from the tip, the ink is non-toxic and will not rub off.
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    K Number
    K051742
    Device Name
    OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
    Manufacturer
    INNTEC, INC.
    Date Cleared
    2005-10-07

    (101 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InnTec, Inc. Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for used and intended to be used for obtaining female gametes / oocytes from the body.
    Device Description
    The Oocyte Retrieval Needle Sets are sterile, single patient use, disposable devices supporting obtaining female gametes/oocytes from the body. The Oocyte Retrieval Needle Sets are packaged in a commercially available, sterile barrier pouch.
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    K Number
    K050521
    Device Name
    EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
    Manufacturer
    INNTEC, INC.
    Date Cleared
    2005-05-02

    (62 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.
    Device Description
    The Embryo Transfer Catheter and Accessory Stylet are sterile, single patient use, disposable devices supporting transfer of an in vitro fertilized embryo to the uterus. The Embryo Transfer Catheter is a 5 Fr Catheter within a 7 Fr Guide Sheath. The 5 Fr Catheter is in contact with the embryo and the uterus. The embryo passes through the Catheter, which is open at the end. The Catheter is available in 18 and 23 cm lengths. The Catheter has marks a 1 cm intervals for depth of insertion. The 7 Fr Guide Sheath provides a smooth passage into the uterus and is open at the end. This Guide Sheath is available in 18 and 23 cm lengths. The Guide Sheath has marks at 1 cm intervals for depth of insertion. Both the 5 Fr Catheter and 7 Fr Guide Sheath have color-coded hubs to indicate the length variation. An optional accessory stylet is available to aid in the initial placement of the Guide Sheath. Both 18 and 23 cm length stylets are available.
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