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510(k) Data Aggregation
K Number
K983713Device Name
PRODIMED MICROINJECTION PIPETTES
Manufacturer
Date Cleared
1999-06-08
(230 days)
Product Code
Regulation Number
884.6130Why did this record match?
Applicant Name (Manufacturer) :
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.
These devices are used for I.C.S.I. (Intra cytoplasmic sperm injection)
Device Description
The holding and injection pipettes were made from 30µl borosilicate glass capillary tubes, 78mm in length and with inner and outer diameters of 0.69 and 0.97mm respectively. The glass pipettes were obtained by drawing thin-walled glass capillary tubes using a horizontal microelectrode puller. The holding pipette was cut and firepolished on a microforge to obtain an outer diamter of 50um and an inner diameter of 20um. To prepare the injection pipette, the pulled capillary was opened on a microgriner to an outer diameter of 7um and an inner diameter of 5um; the bevel angle was 45°. This grinding step required ~3 minutes. The whetstone of the grinder was humidified by a slow water drip during the procedure. The microforge was then used to make a sharp spike on the injection piepette and to bend the edge of the holding and injection pipettes to an angle of ~35° to facilitate the injection procedure in the Petri dish.
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K Number
K990913Device Name
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
Manufacturer
Date Cleared
1999-06-08
(82 days)
Product Code
Regulation Number
884.6100Why 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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