A-A-51050
7 October 1985
COMMERCIAL ITEM DESCRIPTION
GUIDE WIRE, CEREBRAL CATHETER
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers the requirements for a guide wire for use with Bentson Cerebral cardiovascular catheter.
Salient characteristics:
Shall be a sterile, fixed core wire guide with a length of 145 cm and diameter of .032 inches (0.81mm) suitable for use with various angiography catheters.
The guide shall be constructed of tightly spiraled wire over the fixed core surface. The end of the guide shall have a 15 cm flexible tip. The extreme distal 1 cm of the tip shall be soft which shall not kink or separate during manipulation.
The guide wire shall have a bonded herapin coating.
The entire guide wire shall be protected within a plastic guide holder. The holder shall be color coded by guide diameter facilitating identification.
The guide wire shall nontoxic and pyrogen free in accordance with the USP and shall meet any Federal Food And Drug Administration (FDA) requirements for safety and toxicity applicable for invasive and implantable devices.
Each guide wire guide shall be individually wrapped in a suitable, tear resistant peel-open package which will allow aseptic handling and maintain sterility of the contents until opened or damaged. A sterility indicator shall be included in each package. The sterility of the guide wire shall be tested in accordance with the USP.
The guide wire with the plastic holder shall be capable of withstanding ethylene oxide sterilization. The guide wire without the plastic holder shall withstand steam sterilization.
The guide wire shall be fabricated from type 302 austenitic corrosion-resisting steel.
Workmanship. The guide wire shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Bottle (BT). One wire guide, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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