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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00884450691502 00884450691502 K13-05253 PYB Minor surgical procedures tray 1 Merit Medical®
2 00884450692509 00884450692509 K09T-13293A OEZ Cardiovascular procedure kit 2 Merit Medical®
3 00884450691908 00884450691908 K12T-12151A OEQ Angiography/angioplasty kit 2 Merit Medical®
4 00884450691700 00884450691700 K09T-13233A OEZ Cardiovascular procedure kit 2 Merit Medical®
5 00884450708828 00884450708828 K09-14042 OEZ Cardiovascular procedure kit Merit Medical®
6 00884450708705 00884450708705 K12T-04453B OEQ Angiography/angioplasty kit 2 Merit Medical®
7 00884450701508 00884450701508 K12T-09122G OEQ Angiography/angioplasty kit 2 Merit Medical®
8 00884450699300 00884450699300 K09-11108B OEZ Cardiovascular procedure kit Merit Medical®
9 00884450699119 00884450699119 K13-05298 PYB Minor surgical procedures tray Merit Medical®
10 00884450698105 00884450698105 K09T-14025 OEZ Cardiovascular procedure kit 2 Merit Medical®
11 00884450696910 00884450696910 K09-10938B OEZ Cardiovascular procedure kit 2 Merit Medical®
12 00884450696903 00884450696903 K12T-05302J OEQ Angiography/angioplasty kit 2 Merit Medical®
13 00884450696705 00884450696705 K10-05646A PPD Universal drainage tray Merit Medical®
14 00884450696507 00884450696507 K12T-04677B OEQ Angiography/angioplasty kit 2 Merit Medical®
15 00884450696309 00884450696309 K10T-06085 PPD Universal drainage tray 2 Merit Medical®
16 00884450696040 00884450696040 K12T-05303F OEQ Angiography/angioplasty kit 2 Merit Medical®
17 00884450695708 00884450695708 K12T-11626C OEQ Angiography/angioplasty kit 2 Merit Medical®
18 00884450695524 00884450695524 K10-06066 PPD Universal drainage tray 2 Merit Medical®
19 00884450695128 00884450695128 K09-02178R OEZ Cardiovascular procedure kit 2 Merit Medical®
20 00884450693261 00884450693261 K12T-09891H OEQ Angiography/angioplasty kit 2 Merit Medical®
21 00884450692516 00884450692516 K09T-13294A OEZ Cardiovascular procedure kit 2 Merit Medical®
22 00884450691472 00884450691472 K13-05250 PYB Minor surgical procedures tray Merit Medical®
23 00884450691199 00884450691199 K09-10502D OEZ Cardiovascular procedure kit 2 Merit Medical®
24 00884450691182 00884450691182 K12T-12307 OEQ Angiography/angioplasty kit 2 Merit Medical®
25 00884450689882 00884450689882 K09T-12942C OEZ Cardiovascular procedure kit 2 Merit Medical®
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28 00884450687918 00884450687918 K09-14004 OEZ Cardiovascular procedure kit Merit Medical®
29 00884450686515 00884450686515 K12T-12033A OEQ Angiography/angioplasty kit 2 Merit Medical®
30 00884450686102 00884450686102 K10-00805G PPD Universal drainage tray Merit Medical®
31 00884450685914 00884450685914 K10T-05667G PPD Universal drainage tray 2 Merit Medical®
32 00884450685907 00884450685907 K12T-04312T OEQ Angiography/angioplasty kit 2 Merit Medical®
33 00884450685501 00884450685501 K09-14010 OEZ Cardiovascular procedure kit 2 Merit Medical®
34 00884450685105 00884450685105 K12T-06539D OEQ Angiography/angioplasty kit 2 Merit Medical®
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36 00884450684757 00884450684757 K12T-12283 OEQ Angiography/angioplasty kit 2 Merit Medical®
37 00884450684597 00884450684597 K09-11872C OEZ Cardiovascular procedure kit Merit Medical®
38 00884450684535 00884450684535 K12T-09526B OEQ Angiography/angioplasty kit 2 Merit Medical®
39 00884450684511 00884450684511 K12T-01750H OEQ Angiography/angioplasty kit 2 Merit Medical®
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42 00884450683781 00884450683781 56535SIM1/B DQO Catheter, intravascular, diagnostic 2 Impress®
43 00884450683743 00884450683743 510038MPA1/B DQO Catheter, intravascular, diagnostic 2 Impress®
44 00884450683736 00884450683736 510038HH1/B DQO Catheter, intravascular, diagnostic 2 Impress®
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1 00690521015388 15-814 15-814 Padlock Security Tags Batrik Red Padlock Security Tags BATRIK MEDICAL MANUFACTURING INC
2 00643169097865 C01A BONE CEMENT C01A HV-R US KYPHON® HV-R® Bone Cement MEDTRONIC SOFAMOR DANEK, INC.
3 00643169097834 C01B BONE CEMENT C01B HV-R WITH MIXER US KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack MEDTRONIC SOFAMOR DANEK, INC.
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5 00643169097803 CX01A BONE CEMENT CX01A XPEDE US KYPHON® Xpede™ Bone Cement MEDTRONIC SOFAMOR DANEK, INC.
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15 B330OT02240 OT-0224 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. Osseoflex SB Straight Balloon (10ga/4ml) OSSEON LLC
16 B330OT02220 OT-0222 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. Osseoflex SB Straight Balloon (10ga/2ml) OSSEON LLC
17 B330OF82220 OF-8222 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. Osseoflex SB Steerable Balloon (8ga/2ml) OSSEON LLC
18 B330OF02240 OF-0224 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) OSSEON LLC
19 B330OF02220 OF-0222 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. Osseoflex SB Steerable Balloon (10ga/2ml) OSSEON LLC
20 B330OF00050 OF-0005 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. Osseoflex SB Steerable Balloon (8ga/ 4ml) OSSEON LLC
21 30808232000949 2110-0031 2110-0031 Mix Tips, Luer Cortoss STRYKER CORPORATION
22 28031497001382 13C2040 Mendec Spine HV System is indicated for the treatment of pathological fractures Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine HV System is a closed sysyem which containes the powder and liquid components separately.The device is disposable and sterile. Mendec Spine HV System TECRES SPA
23 28031497000521 13C2000 Mendec Spine Kit is a device for the treatment of pathological fractures of the Mendec Spine Kit is a device for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure.The device is composed by an acrylic resin and a delivery system. Mendec Spine Kit TECRES SPA
24 28031497000101 1230 Mendec Spine is an acrylic resin for the treatment of pathological fractures of Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application.The device is sold disposable and sterile Mendec Spine TECRES SPA
25 15056033810538 INTV-CEM Osteoflex PAN MEDICAL US CORPORATION
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