NeedleZap™ - P010065
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: NeedleZap™
Applicant: E Med Future, Inc.
Address: 794 Morrison Road , Colombus, Ohio 43230
Approval Date: March 14, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p010065a.pdf
What is it? The NeedleZap™ is a portable needle destruction device that incinerates 16-30 gauge ¾ to 2 inch aluminum and stainless steel hypodermic needles. When a needle is inserted into the opening, two D sized rechargeable batteries deliver 2.5 amps of electrical current to destroy the needle.
How does it work? The NeedleZap™ needles are burned as a result of the delivery of a 2.5A current between two electrodes inside the device.
When is it used? The NeedleZap™ is used by healthcare personnel in hospitals, doctors’ offices, and clinics to destroy the needles once they have been used.
What will it accomplish? The use of this device is an alternative to puncture resistant sharps containers. Using the device reduces the chance of a needlestick injury.
When should it not be used? The NeedleZap™ should not be used near flammable liquids, gases, oxygen, operating rooms, or explosives. It should not be used to destroy needles that contain explosive or radioactive materials.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010065