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510(k) Data Aggregation

    K Number
    K990913
    Device Name
    HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
    Date Cleared
    1999-06-08

    (82 days)

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

    LABORATOIRES PRODIMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
    Device Description
    H.O.C. Set™ Hazout oocyte collector with or without valve Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip Optional: 3-way valve The device features a simple flux metallic needle, 30 cm in useful length, 17 gauge in outside diameter and 18 gauge in inside diameter, with double chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a 30 ml round-bottomed vial fitted with a screw-cap, or to a 30 ml round-bottomed vial fitted with a flexible cap (model HOC Set 2). The model with a three-way valve set between the puncture needle and the collecting vial allows suction and rinsing of the follicles in turn. Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. H.O.C. vials are also sold alone by 50 units. O.P.S. Oocyte Puncture Set™ Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip The device features a simple flux metallic needle, 30 cm in useful length and 17 gauge in outer diameter and 18 gauge in inside diameter, with doublechambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. The device must be connected to an irradiation sterilized Falcon tube. The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a Falcon tube. Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. Luer-lock Needle for Ovum recovery Needle: 25 cm or 30 cm; O.D. 17 gauge, echogenic tip; I.D. 18 gauge Simple flux steel needle, 17 gauge in outside diameter and 18 gauge in inside diameter, with double-chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. Two sizes: 25 cm or 30 cm long. The needle has a Luer-lock to attach a syringe, and a green plastic inner madrel. The needle is placed in a Teflon packing tubing for protection. Packaging: Disposable device in single unit sealed bag. Irradiation sterilized. Available in 10 unit packs.
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