A-A-51343
Shall have a transparent adhesive backed incise drape, approximately 13 by 16 inches (33 by 40.6 cm). Shall have a non-adhesive tab on each side of the length to aid in application.
Shall have a large size impervious stockinette, approximately 9 by 48 inches (22.8 by 121.9 cm). Shall be rolled to permit aseptic application.
All items except the Mayo cover and stockinette, shall be fabricated of a soft nonwoven fabric, with minimal memory for good drapeability. Shall resist tearing, pilling and linting.
�Directions for Proper Placement� shall be clearly imprinted on each drape.
If the pack is inadvertently opened and not used, shall be capable of sterilization by steam or ethylene oxide.
The pack shall be sterile and individually wrapped in a suitable tear resistant, heat sealed package which will allow aseptic handling and maintain sterility of the contents until opened or damaged.
Each pack shall be also wrapped in a heat sealed exterior dust cover.
All pack components shall be clearly listed on the exterior wrapper.
Workmanship. The surgical pack shall be free from defects which detract from its appearance or impair its serviceability.
�The surgical pack shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing three (3) individually� packaged surgical packs, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers� own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
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