BERKLEY MEDICAL RESOURCES, INC. 4505E Splash Shield

Device Classification Name System, X-Ray, Mammographic510(K) Number K891090

Vision brush 02 (synthetic)

Dental crown/bridge, temporary

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.

Dry Shield™ Fluid Resistant Mask 160mm, Earloop, Anti-Glare/Anti-Fog Visor,

Dry Shield™ Fluid Resistant Mask 160mm, Tie, Anti-Glare/Anti-Fog Visor, Ice

Dry Shield™ Fluid Resistant Mask 160mm, Tie w/o Visor, Ice Blue (USA)

ISLANDER EYES 444 POLARIZED SUNGLASSES

Liquichek Urine Toxicology Control Level C4 (A human urine drugs of abuse control)

Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

Device Classification Name System, X-Ray, Mammographic510(K) Number K891090

Vision brush 02 (synthetic)

Dental crown/bridge, temporary

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.