ABAXIS, INC. 1100-1511 Piccolo Xpress Military Deployment Kit

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s). An access channel is required for the Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to it's start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

The Vitros 5600 integrated system, recently calibrated and unused. The System is a lab workhorse designed to run clinical chemistry and immunoassay testing with a throughput of more than 900 tests per hour.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum.The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests.Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.

Brush & Micro Tips Kit, 100 Brush Tips & 5 Handles

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s). An access channel is required for the Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to it's start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.