A-A-54303
Plunger shall be 7.5 ± 0.1 inches long from handle brace to tip with a body diameter of 0.10 inches and a distal end diameter of 0.11 inches. plunger shall have a finger ring on the proximal end for use in manipulating the plunger. The IUD shall be 1.245 to 1.270 inches wide by 1.405 to 1.425 inches high with at least 4-1/2 inches of polyethylene string attached to the bulb. The plastic body shall be 0.064 inches in diameter. The copper bands shall be 0.0198 inches wide each located 7/32 inches from the vertical portion of the “T”.
Instructions. Instructions for use shall be provided with each IUD which shall also contain a minimum of one patient information brochure and one patient wallet card. Shall also contain additional pertinent information on the item for physician use.
Biocompatibility. The IUD shall meet the requirements of the USP for Class II plastics.
Sterility. The set components and inside surfaces of the containing envelope shall be sterile and have a minimum quality assurance level of 0.000001 in accordance with AAMI guidelines.
Shelf life. A minimum of 40 months shelf life shall remain on shipment of the IUD to the Government.
Workmanship. The IUD shall be free from defects which detract from its appearance or impair its serviceability. Shall be free from pits, cracks, distortion, corrosion, burrs, sharp edges or foreign material.
Unit. Package (PG). One package containing five individually packaged sterile intrauterine devices, with instruction for use, as specified, constitutes one unit. Each device shall be packaged in a peel back containing for aseptic removal. The individual package shall be a sealed peel-open container capable of maintaining sterility of contents unless the package is damaged or opened.
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