COMMERCIAL ITEM DESCRIPTION A-A-51445
d. One 20 gauge needle with cleaning wire. Needle 20 gauge portion shall be 1 inch long with an overall length of 2 inches. Shall be threaded on the proximal end for attachment to a handpiece. Flats shall be provided on the expanded proximal section for tightening into the handpiece. Needle and wire shall be Class 3, Type 304 corrosion-resisting steel.
e. One 20 cc disposable plastic syringe with markings at each cc increment from 1 to 20 cc.
f. One three-way plastic stopcock with Luer fittings to attach to syringe and debris line fittings. Control handle shall be marked with flow direction arrows and off position.
Material. Corrosion-resisting steel shall be in accordance with ASTM Designation F899, Stainless Steel Billet, Bar, and Wire For Surgical Instruments.
Luer fittings. Luer fitting shall be in accordance with ANSI/HIMA MD70.1
Sterility. The kit components shall be sterile when tested in accordance with the United States Pharmacopeia (USP).
Safety. The needle and internal surfaces of the tubing, syringe and stopcock shall be non-pyrogenic and no-toxic in accordance with USP requirements. Plastic components coming in contact with fluids entering the eye shall contain no more than 5 parts per million of lead.
Workmanship. The kit shall be free from defects which detract from their appearance or impair their serviceability. Plastic components shall be free from dents, kinks, pits, blisters, cuts, holes, and scratches. Metal components shall be free from dents, pits burs, slivers, scale and corrosion. Needle shall not be bent, shall be sharp and shall be free from feathered edges.
Unit. Package (PG). One package containing six kits, each kit individually packaged sterile in a peel-open type container, constitutes one unit.
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